← Back to catalogue

GORE-TEX Suture Oral Health

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 5K02Ref 0U01Ref 5N10Ref 2N13Ref 7J06Ref 4N10Ref 4N16Ref 7K08Ref 5N14Ref 3U08Ref 6J02Ref 6M10Ref 0N07Ref 3N14Ref 7M06Ref 7K02Ref 3N07Ref 7K04Ref 8K02Ref 7K06Ref 2N06Ref 4U16Ref 5N20Ref 4N12Ref 8M02Ref 8M06Ref 3U20Ref 6M12Ref 0N05Ref 2P08Ref P6K23Ref 2N23Ref 6K10Ref 5K12Ref 6K12Ref 4N02Ref 3P24Ref 2N07Ref 5M16Ref 2N19Ref 2U02Ref 7M08Ref P4K13Ref 3201Ref 5M12Ref 6M14Ref 6K08Ref 3N10Ref 6K02Ref 2U10Ref 2N10Ref 5N12Ref P6K25Ref 6M08Ref 5K08Ref 8M08Ref 2N02Ref M2U28Ref 4U02Ref 6N04Ref 7J04Ref 5N08Ref 6M02Ref 6N16Ref 7J10Ref 2N05Ref 0N09

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE-TEX Suture Oral Health FDA UDI
GORE-TEX Suture FDA UDI
GORE-TEX Suture FDA UDI
Generic Name
Polyolefin/fluoropolymer suture, monofilament FDA UDI
Cardiovascular patch, synthetic FDA UDI
Device Name
GORE-TEX® Suture EUDAMED
GORE-TEX SUTURE CV-7 61cm RT-11-1dz FDA UDI
GORE-TEX SUTURE CV-8 61cm DoubleArm TTc-9-1dz FDA UDI
GORE-TEX SUTURE CV-5 61cm DoubleArm TTc-13-1dz FDA UDI
GORE-TEX SUTURE CV-7 46cm DoubleArm THc-13-1dz FDA UDI
GORE-TEX SUTURE CV-5 91cm DoubleArm PT-13-1dz FDA UDI
GORE-TEX SUTURE CV-6 61cm DoubleArm TTc-9-1dz FDA UDI
GORE-TEX SUTURE CV-3 122cm DoubleArm TH-26-1dz FDA UDI
GORE-TEX SUTURE CV-7 61cm DoubleArm TTc-9-1dz FDA UDI
GORE-TEX SUTURE CV-4 91cm DoubleArm PT-17-1dz FDA UDI
GORE-TEX SUTURE CV-6 46cm DoubleArm TTc-9-1dz FDA UDI
GORE-TEX SUTURE CV-7 61cm DoubleArm PT-9-1dz FDA UDI
GORE-TEX SUTURE CV-2 91cm SingleArm THX-25-1dz FDA UDI
GORE-TEX SUTURE CV-0 91cm SingleArm THX-26-1dz FDA UDI
GORE-TEX SUTURE CV-5 91cm DoubleArm PT-17-1dz FDA UDI
GORE-TEX SUTURE CV-2 91cm DoubleArm PH-24-1dz FDA UDI
GORE-TEX SUTURE CV-5 91cm DoubleArm TPH-26-1dz FDA UDI
GORE-TEX SUTURE CV-2 122cm DoubleArm PH-24-1dz FDA UDI
GORE-TEX SUTURE CV-6 61cm DoubleArm TTc-12-1dz FDA UDI
GORE-TEX SUTURE CV-6 76cm DoubleArm THc-13-1dz FDA UDI
GORE-TEX SUTURE CV-6 76cm DoubleArm PH-13-1dz FDA UDI
GORE-TEX SUTURE CV-2 91cm DoubleArm THX-26-1dz FDA UDI
GORE-TEX SUTURE CV-6 76cm DoubleArm TTc-12-1dz FDA UDI
GORE-TEX SUTURE CV-8 76cm DoubleArm PT-13-1dz FDA UDI
GORE-TEX SUTURE CV-3 91cm DoubleArm PH-24-1dz FDA UDI
GORE-TEX SUTURE CV-5 76cm DoubleArm PH-13-1dz FDA UDI
GORE-TEX SUTURE CV-6 91cm DoubleArm TH-18-1dz FDA UDI
GORE-TEX SUTURE CV-2 91cm SingleArm TFX-25-1dz FDA UDI
GORE-TEX SUTURE CV-2 91cmDoubleArm TH-26-1dz FDA UDI
GORE-TEX SUTURE CV-4 122cm DoubleArm TH-18-1dz FDA UDI
GORE-TEX SUTURE CV-6 76cm DoubleArm TTc-9-1dz FDA UDI
GORE-TEX SUTURE CV-3 91cm SingleArm TH-26-1dz FDA UDI
GORE-TEX SUTURE CV-5 61cm DoubleArm PT-13-1dz FDA UDI
GORE-TEX SUTURE CV-5 61cm DoubleArm THc-13-1dz FDA UDI
GORE-TEX SUTURE CV-3 107cm DoubleArm PH-30-1dz FDA UDI
GORE-TEX SUTURE CV-7 76cm DoubleArm PT-13-1dz FDA UDI
GORE-TEX SUTURE CV-2 91cm SingleArm THX-36-1dz FDA UDI
GORE-TEX SUTURE CV-4 91cm DoubleArm PH-24-1dz FDA UDI
GORE-TEX SUTURE CV-6 91cm DoubleArm TTc-13-1dz FDA UDI
GORE-TEX SUTURE CV-0 91cm SingleArm TFX-25-1dz FDA UDI
GORE-TEX SUTURE CV-7 46cm DoubleArm PT-9-1dz FDA UDI
CV-2 SUTURE 48"PS-4 THX-26 1DZ FDA UDI
GORE-TEX SUTURE CV-6 61cm DoubleArm PT-13-1dz FDA UDI
GORE-TEX SUTURE CV-0 91cm SingleArm THX-36-1dz FDA UDI
GORE-TEX SUTURE CV-5 91cm DoubleArm PH-17-1dz FDA UDI
GORE-TEX SUTURE CV-7 46cm DoubleArm TTc-13-1dz FDA UDI
GORE-TEX SUTURE CV-3 91cm DoubleArm PT-17-1dz FDA UDI
GORE-TEX SUTURE CV-2 107cm DoubleArm THX36-1dz FDA UDI
GORE-TEX SUTURE CV-7 76cm DoubleArm TTc-13-1dz FDA UDI
GORE-TEX SUTURE CV-2 91cm SingleArm THX-26-1dz FDA UDI
GORE-TEX SUTURE CV-2 91cm SingleArm TS-50-1dz FDA UDI
GORE-TEX SUTURE CV-3 122cm DoubleArm PH-35-1dz FDA UDI
GORE-TEX SUTURE CV-4 122cm DoubleArm PH-24-1dz FDA UDI
GORE-TEX SUTURE CV-5 76cm DoubleArm THc-13-1dz FDA UDI
GORE-TEX SUTURE CV-4 91cm DoubleArm TH-18-1dz FDA UDI
GORE-TEX SUTURE CV-6 76cm DoubleArm PT-13-1dz FDA UDI
GORE-TEX SUTURE CV-7 61cm DoubleArm TTc-13-1dz FDA UDI
GORE-TEX SUTURE CV-4 91cm DoubleArm TH-35-1dz FDA UDI
GORE-TEX SUTURE CV-8 76cm DoubleArm TTc-9-1dz FDA UDI
GORE-TEX SUTURE CV-6 61cm RT-13-1dz FDA UDI
GORE-TEX SUTURE CV-8 76cm DoubleArm PT-9-1dz FDA UDI
GORE-TEX SUTURE CV-4 61cm RT-18-1dz FDA UDI
GORE-TEX SUTURE CV-0 122cm SingleArm TH-50-1dz FDA UDI
GORE-TEX SUTURE CV-2 122cm DoubleArm TH-26-1dz FDA UDI
GORE-TEX SUTURE CHORDAE TENDIN CV-5 91cm DoubleArm TH-22-1dz FDA UDI
GORE-TEX SUTURE CV-6 61cm DoubleArm THc-13-1dz FDA UDI
GORE-TEX SUTURE CV-6 61cm RH-16-1dz FDA UDI
GORE-TEX SUTURE CV-7 61cm DoubleArm PT-13-1dz FDA UDI
GORE-TEX SUTURE CV-5 91cm DoubleArm THc-13-1dz FDA UDI
Model / Reference
8K02 EUDAMEDFDA UDI
5K02 EUDAMEDFDA UDI
7J10 EUDAMEDFDA UDI
5N08 EUDAMEDFDA UDI
6K02 EUDAMEDFDA UDI
3U08 EUDAMEDFDA UDI
7K02 EUDAMEDFDA UDI
4N10 EUDAMEDFDA UDI
6J02 EUDAMEDFDA UDI
7K04 EUDAMEDFDA UDI
2N13 EUDAMEDFDA UDI
0N05 EUDAMEDFDA UDI
5N10 EUDAMEDFDA UDI
2N10 EUDAMEDFDA UDI
5N20 EUDAMEDFDA UDI
2U10 EUDAMEDFDA UDI
6K10 EUDAMEDFDA UDI
6M12 EUDAMEDFDA UDI
6M14 EUDAMEDFDA UDI
2N06 EUDAMEDFDA UDI
6M10 EUDAMEDFDA UDI
8M06 EUDAMEDFDA UDI
3N10 EUDAMEDFDA UDI
5M16 EUDAMEDFDA UDI
6N16 EUDAMEDFDA UDI
2N19 EUDAMEDFDA UDI
2N02 EUDAMEDFDA UDI
4U02 EUDAMEDFDA UDI
6M02 EUDAMEDFDA UDI
3N07 EUDAMEDFDA UDI
5K08 EUDAMEDFDA UDI
5K12 EUDAMEDFDA UDI
3P24 EUDAMEDFDA UDI
7M08 EUDAMEDFDA UDI
2N07 EUDAMEDFDA UDI
4N16 EUDAMEDFDA UDI
6N04 EUDAMEDFDA UDI
0N09 EUDAMEDFDA UDI
7J04 EUDAMEDFDA UDI
M2U28 EUDAMEDFDA UDI
6K08 EUDAMEDFDA UDI
0N07 EUDAMEDFDA UDI
5N14 EUDAMEDFDA UDI
7J06 EUDAMEDFDA UDI
3N14 EUDAMEDFDA UDI
2P08 EUDAMEDFDA UDI
7M06 EUDAMEDFDA UDI
2N05 EUDAMEDFDA UDI
2N23 EUDAMEDFDA UDI
3U20 EUDAMEDFDA UDI
4U16 EUDAMEDFDA UDI
5M12 EUDAMEDFDA UDI
4N02 EUDAMEDFDA UDI
6M08 EUDAMEDFDA UDI
7K06 EUDAMEDFDA UDI
4N12 EUDAMEDFDA UDI
8M02 EUDAMEDFDA UDI
P6K23 EUDAMEDFDA UDI
8M08 EUDAMEDFDA UDI
P4K13 EUDAMEDFDA UDI
0U01 EUDAMEDFDA UDI
2U02 EUDAMEDFDA UDI
3201 EUDAMEDFDA UDI
6K12 EUDAMEDFDA UDI
P6K25 EUDAMEDFDA UDI
7K08 EUDAMEDFDA UDI
5N12 EUDAMEDFDA UDI
P7K13 FDA UDI
Description
GORE-TEX SUTURE CV-7 61cm RT-11-1dz FDA UDI
GORE-TEX SUTURE CV-8 61cm DoubleArm TTc-9-1dz FDA UDI
GORE-TEX SUTURE CV-5 61cm DoubleArm TTc-13-1dz FDA UDI
GORE-TEX SUTURE CV-7 46cm DoubleArm THc-13-1dz FDA UDI
GORE-TEX SUTURE CV-5 91cm DoubleArm PT-13-1dz FDA UDI
GORE-TEX SUTURE CV-6 61cm DoubleArm TTc-9-1dz FDA UDI
GORE-TEX SUTURE CV-3 122cm DoubleArm TH-26-1dz FDA UDI
GORE-TEX SUTURE CV-7 61cm DoubleArm TTc-9-1dz FDA UDI
GORE-TEX SUTURE CV-4 91cm DoubleArm PT-17-1dz FDA UDI
GORE-TEX SUTURE CV-6 46cm DoubleArm TTc-9-1dz FDA UDI
GORE-TEX SUTURE CV-7 61cm DoubleArm PT-9-1dz FDA UDI
GORE-TEX SUTURE CV-2 91cm SingleArm THX-25-1dz FDA UDI
GORE-TEX SUTURE CV-0 91cm SingleArm THX-26-1dz FDA UDI
GORE-TEX SUTURE CV-5 91cm DoubleArm PT-17-1dz FDA UDI
GORE-TEX SUTURE CV-2 91cm DoubleArm PH-24-1dz FDA UDI
GORE-TEX SUTURE CV-5 91cm DoubleArm TPH-26-1dz FDA UDI
GORE-TEX SUTURE CV-2 122cm DoubleArm PH-24-1dz FDA UDI
GORE-TEX SUTURE CV-6 61cm DoubleArm TTc-12-1dz FDA UDI
GORE-TEX SUTURE CV-6 76cm DoubleArm THc-13-1dz FDA UDI
GORE-TEX SUTURE CV-6 76cm DoubleArm PH-13-1dz FDA UDI
GORE-TEX SUTURE CV-2 91cm DoubleArm THX-26-1dz FDA UDI
GORE-TEX SUTURE CV-6 76cm DoubleArm TTc-12-1dz FDA UDI
GORE-TEX SUTURE CV-8 76cm DoubleArm PT-13-1dz FDA UDI
GORE-TEX SUTURE CV-3 91cm DoubleArm PH-24-1dz FDA UDI
GORE-TEX SUTURE CV-5 76cm DoubleArm PH-13-1dz FDA UDI
GORE-TEX SUTURE CV-6 91cm DoubleArm TH-18-1dz FDA UDI
GORE-TEX SUTURE CV-2 91cm SingleArm TFX-25-1dz FDA UDI
GORE-TEX SUTURE CV-2 91cmDoubleArm TH-26-1dz FDA UDI
GORE-TEX SUTURE CV-4 122cm DoubleArm TH-18-1dz FDA UDI
GORE-TEX SUTURE CV-6 76cm DoubleArm TTc-9-1dz FDA UDI
GORE-TEX SUTURE CV-3 91cm SingleArm TH-26-1dz FDA UDI
GORE-TEX SUTURE CV-5 61cm DoubleArm PT-13-1dz FDA UDI
GORE-TEX SUTURE CV-5 61cm DoubleArm THc-13-1dz FDA UDI
GORE-TEX SUTURE CV-3 107cm DoubleArm PH-30-1dz FDA UDI
GORE-TEX SUTURE CV-7 76cm DoubleArm PT-13-1dz FDA UDI
GORE-TEX SUTURE CV-2 91cm SingleArm THX-36-1dz FDA UDI
GORE-TEX SUTURE CV-4 91cm DoubleArm PH-24-1dz FDA UDI
GORE-TEX SUTURE CV-6 91cm DoubleArm TTc-13-1dz FDA UDI
GORE-TEX SUTURE CV-0 91cm SingleArm TFX-25-1dz FDA UDI
GORE-TEX SUTURE CV-7 46cm DoubleArm PT-9-1dz FDA UDI
CV-2 SUTURE 48"PS-4 THX-26 1DZ FDA UDI
GORE-TEX SUTURE CV-6 61cm DoubleArm PT-13-1dz FDA UDI
GORE-TEX SUTURE CV-0 91cm SingleArm THX-36-1dz FDA UDI
GORE-TEX SUTURE CV-5 91cm DoubleArm PH-17-1dz FDA UDI
GORE-TEX SUTURE CV-7 46cm DoubleArm TTc-13-1dz FDA UDI
GORE-TEX SUTURE CV-3 91cm DoubleArm PT-17-1dz FDA UDI
GORE-TEX SUTURE CV-2 107cm DoubleArm THX36-1dz FDA UDI
GORE-TEX SUTURE CV-7 76cm DoubleArm TTc-13-1dz FDA UDI
GORE-TEX SUTURE CV-2 91cm SingleArm THX-26-1dz FDA UDI
GORE-TEX SUTURE CV-2 91cm SingleArm TS-50-1dz FDA UDI
GORE-TEX SUTURE CV-3 122cm DoubleArm PH-35-1dz FDA UDI
GORE-TEX SUTURE CV-4 122cm DoubleArm PH-24-1dz FDA UDI
GORE-TEX SUTURE CV-5 76cm DoubleArm THc-13-1dz FDA UDI
GORE-TEX SUTURE CV-4 91cm DoubleArm TH-18-1dz FDA UDI
GORE-TEX SUTURE CV-6 76cm DoubleArm PT-13-1dz FDA UDI
GORE-TEX SUTURE CV-7 61cm DoubleArm TTc-13-1dz FDA UDI
GORE-TEX SUTURE CV-4 91cm DoubleArm TH-35-1dz FDA UDI
GORE-TEX SUTURE CV-8 76cm DoubleArm TTc-9-1dz FDA UDI
GORE-TEX SUTURE CV-6 61cm RT-13-1dz FDA UDI
GORE-TEX SUTURE CV-8 76cm DoubleArm PT-9-1dz FDA UDI
GORE-TEX SUTURE CV-4 61cm RT-18-1dz FDA UDI
GORE-TEX SUTURE CV-0 122cm SingleArm TH-50-1dz FDA UDI
GORE-TEX SUTURE CV-2 122cm DoubleArm TH-26-1dz FDA UDI
GORE-TEX SUTURE CHORDAE TENDIN CV-5 91cm DoubleArm TH-22-1dz FDA UDI
GORE-TEX SUTURE CV-6 61cm DoubleArm THc-13-1dz FDA UDI
GORE-TEX SUTURE CV-6 61cm RH-16-1dz FDA UDI
GORE-TEX SUTURE CV-7 61cm DoubleArm PT-13-1dz FDA UDI
GORE-TEX SUTURE CV-5 91cm DoubleArm THc-13-1dz FDA UDI

Identifiers

Catalog Number
P7K13 FDA UDI
8K02 FDA UDI
5K02 FDA UDI
7J10 FDA UDI
5N08 FDA UDI
6K02 FDA UDI
3U08 FDA UDI
7K02 FDA UDI
4N10 FDA UDI
6J02 FDA UDI
7K04 FDA UDI
2N13 FDA UDI
0N05 FDA UDI
5N10 FDA UDI
2N10 FDA UDI
5N20 FDA UDI
2U10 FDA UDI
6K10 FDA UDI
6M12 FDA UDI
6M14 FDA UDI
2N06 FDA UDI
6M10 FDA UDI
8M06 FDA UDI
3N10 FDA UDI
5M16 FDA UDI
6N16 FDA UDI
2N19 FDA UDI
2N02 FDA UDI
4U02 FDA UDI
6M02 FDA UDI
3N07 FDA UDI
5K08 FDA UDI
5K12 FDA UDI
3P24 FDA UDI
7M08 FDA UDI
2N07 FDA UDI
4N16 FDA UDI
6N04 FDA UDI
0N09 FDA UDI
7J04 FDA UDI
M2U28 FDA UDI
6K08 FDA UDI
0N07 FDA UDI
5N14 FDA UDI
7J06 FDA UDI
3N14 FDA UDI
2P08 FDA UDI
7M06 FDA UDI
2N05 FDA UDI
2N23 FDA UDI
3U20 FDA UDI
4U16 FDA UDI
5M12 FDA UDI
4N02 FDA UDI
6M08 FDA UDI
7K06 FDA UDI
4N12 FDA UDI
8M02 FDA UDI
P6K23 FDA UDI
8M08 FDA UDI
P4K13 FDA UDI
0U01 FDA UDI
2U02 FDA UDI
3201 FDA UDI
6K12 FDA UDI
P6K25 FDA UDI
7K08 FDA UDI
5N12 FDA UDI
Primary DI / UDI-DI
00733132629848 EUDAMEDFDA UDI
00733132629015 EUDAMEDFDA UDI
00733132629459 EUDAMEDFDA UDI
00733132629114 EUDAMEDFDA UDI
00733132629268 EUDAMEDFDA UDI
00733132628780 EUDAMEDFDA UDI
00733132629466 EUDAMEDFDA UDI
00733132628858 EUDAMEDFDA UDI
00733132629169 EUDAMEDFDA UDI
00733132629749 EUDAMEDFDA UDI
00733132628551 EUDAMEDFDA UDI
00733132625789 EUDAMEDFDA UDI
00733132629121 EUDAMEDFDA UDI
00733132628544 EUDAMEDFDA UDI
00733132629152 EUDAMEDFDA UDI
00733132628629 EUDAMEDFDA UDI
00733132629305 EUDAMEDFDA UDI
00733132629374 EUDAMEDFDA UDI
00733132629381 EUDAMEDFDA UDI
00733132628513 EUDAMEDFDA UDI
00733132629367 EUDAMEDFDA UDI
00733132629886 EUDAMEDFDA UDI
00733132628735 EUDAMEDFDA UDI
00733132629077 EUDAMEDFDA UDI
00733132629411 EUDAMEDFDA UDI
00733132628568 EUDAMEDFDA UDI
00733132628957 EUDAMEDFDA UDI
00733132628971 EUDAMEDFDA UDI
00733132629329 EUDAMEDFDA UDI
00733132628711 EUDAMEDFDA UDI
00733132629022 EUDAMEDFDA UDI
00733132629046 EUDAMEDFDA UDI
00733132628766 EUDAMEDFDA UDI
00733132629800 EUDAMEDFDA UDI
00733132628520 EUDAMEDFDA UDI
00733132628872 EUDAMEDFDA UDI
00733132629404 EUDAMEDFDA UDI
00733132628889 EUDAMEDFDA UDI
00733132629435 EUDAMEDFDA UDI
00733132629909 EUDAMEDFDA UDI
00733132629299 EUDAMEDFDA UDI
00733132626106 EUDAMEDFDA UDI
00733132629145 EUDAMEDFDA UDI
00733132629442 EUDAMEDFDA UDI
00733132628759 EUDAMEDFDA UDI
00733132628582 EUDAMEDFDA UDI
00733132629794 EUDAMEDFDA UDI
00733132628483 EUDAMEDFDA UDI
00733132628575 EUDAMEDFDA UDI
00733132628803 EUDAMEDFDA UDI
00733132628995 EUDAMEDFDA UDI
00733132629060 EUDAMEDFDA UDI
00733132628810 EUDAMEDFDA UDI
00733132629350 EUDAMEDFDA UDI
00733132629756 EUDAMEDFDA UDI
00733132628865 EUDAMEDFDA UDI
00733132629879 EUDAMEDFDA UDI
00733132629954 EUDAMEDFDA UDI
00733132629893 EUDAMEDFDA UDI
00733132629916 EUDAMEDFDA UDI
00733132628902 EUDAMEDFDA UDI
00733132628599 EUDAMEDFDA UDI
00733132628667 EUDAMEDFDA UDI
00733132629312 EUDAMEDFDA UDI
00733132629930 EUDAMEDFDA UDI
00733132629763 EUDAMEDFDA UDI
00733132629138 EUDAMEDFDA UDI
00733132628490 FDA UDI
Basic UDI-DI
B-00733132629015 EUDAMED
B-00733132628902 EUDAMED
B-00733132629121 EUDAMED
B-00733132628551 EUDAMED
B-00733132629442 EUDAMED
B-00733132628858 EUDAMED
B-00733132628872 EUDAMED
B-00733132629763 EUDAMED
B-00733132629145 EUDAMED
B-00733132628780 EUDAMED
B-00733132629169 EUDAMED
B-00733132629367 EUDAMED
B-00733132626106 EUDAMED
B-00733132628759 EUDAMED
B-00733132629794 EUDAMED
B-00733132629466 EUDAMED
B-00733132628711 EUDAMED
B-00733132629749 EUDAMED
B-00733132629848 EUDAMED
B-00733132629756 EUDAMED
B-00733132628513 EUDAMED
B-00733132628995 EUDAMED
B-00733132629152 EUDAMED
B-00733132628865 EUDAMED
B-00733132629879 EUDAMED
B-00733132629886 EUDAMED
B-00733132628803 EUDAMED
B-00733132629374 EUDAMED
B-00733132625789 EUDAMED
B-00733132628582 EUDAMED
B-00733132629954 EUDAMED
B-00733132628575 EUDAMED
B-00733132629305 EUDAMED
B-00733132629046 EUDAMED
B-00733132629312 EUDAMED
B-00733132628810 EUDAMED
B-00733132628766 EUDAMED
B-00733132628520 EUDAMED
B-00733132629077 EUDAMED
B-00733132628568 EUDAMED
B-00733132628599 EUDAMED
B-00733132629800 EUDAMED
B-00733132629916 EUDAMED
B-00733132628667 EUDAMED
B-00733132629060 EUDAMED
B-00733132629381 EUDAMED
B-00733132629299 EUDAMED
B-00733132628735 EUDAMED
B-00733132629268 EUDAMED
B-00733132628629 EUDAMED
B-00733132628544 EUDAMED
B-00733132629138 EUDAMED
B-00733132629930 EUDAMED
B-00733132629350 EUDAMED
B-00733132629022 EUDAMED
B-00733132629893 EUDAMED
B-00733132628957 EUDAMED
B-00733132629909 EUDAMED
B-00733132628971 EUDAMED
B-00733132629404 EUDAMED
B-00733132629435 EUDAMED
B-00733132629114 EUDAMED
B-00733132629329 EUDAMED
B-00733132629411 EUDAMED
B-00733132629459 EUDAMED
B-00733132628483 EUDAMED
B-00733132628889 EUDAMED
PMA Number
P820083 FDA UDI
FDA Product Code
GAW FDA UDI
EMDN Code
H010201010501 POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE EUDAMED
GMDN Term
Polyolefin/fluoropolymer suture, monofilament FDA UDI
Cardiovascular patch, synthetic FDA UDI

Classification

Device Class
Class III EUDAMED
Class II FDA UDI
Regulation Number
878.5010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 61 Centimeter FDA UDI
Length — 46 Centimeter FDA UDI
Length — 91 Centimeter FDA UDI
Length — 122 Centimeter FDA UDI
Length — 76 Centimeter FDA UDI
Length — 107 Centimeter FDA UDI

Category: Polyolefin/fluoropolymer suture, monofilament

GORE-TEX Suture Oral Health by W. L. Gore & Associates, Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Polyolefin/fluoropolymer suture, monofilament.

Cleared under the same submission

P820083 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
W. L. Gore & Associates, Inc

Sources (135)

  • FDA UDI a4adf7c4-fb3f-47ff-b6cd-f6741c3e8b0e 37 fields · synced Sep 18, 2026
  • FDA UDI 0629f132-2f3d-4109-809d-1c7c21316865 37 fields · synced May 27, 2026
  • FDA UDI b2e7ca60-a692-4a34-975d-31dd4b74b493 37 fields · synced May 29, 2026
  • FDA UDI 141c8b8c-b7c4-4099-8c68-6069a128dac6 37 fields · synced May 29, 2026
  • FDA UDI 7fb284c9-ecc9-451a-a86c-5c1197f3bbdc 37 fields · synced May 29, 2026
  • FDA UDI b3d37341-998e-4362-b07f-bcb82d7892bd 37 fields · synced May 29, 2026
  • FDA UDI dfc06b16-d9c6-4a5b-9f1d-fb48937b31e7 37 fields · synced May 29, 2026
  • FDA UDI 15d67108-1708-4a58-9404-0a14fc8c5d7d 37 fields · synced May 29, 2026
  • FDA UDI 73db35f8-9660-442f-b80b-91d0e8af5080 37 fields · synced May 29, 2026
  • FDA UDI c1046ef7-e28e-418e-a02c-d31c418cfabd 37 fields · synced May 29, 2026
  • FDA UDI daa06f20-7666-4cfb-903a-76d8a5c5af51 37 fields · synced May 30, 2026
  • FDA UDI 788785ef-50f2-46f7-a7ef-cb01de61fac4 37 fields · synced May 30, 2026
  • FDA UDI 007f8473-facd-42a5-b9e4-d74da2de1065 37 fields · synced May 30, 2026
  • FDA UDI 57696099-1b47-441d-9423-d89a20afd611 37 fields · synced May 30, 2026
  • FDA UDI a14c776b-dc77-4fbd-927e-6d98281c02f4 37 fields · synced May 30, 2026
  • FDA UDI 297c5a36-f884-4c7b-9c70-f71b93f6547f 37 fields · synced May 30, 2026
  • FDA UDI 50271368-bc63-4024-8124-9b9d8ac32ad2 37 fields · synced May 30, 2026
  • FDA UDI 3047717b-e8fe-4b4f-95c2-93bf8965808c 37 fields · synced May 30, 2026
  • FDA UDI 3c062e5a-2a11-43da-8a3f-203e1bb08e6d 37 fields · synced May 30, 2026
  • FDA UDI 292b7d1c-065e-4ae9-87ae-68a7ab623283 37 fields · synced May 30, 2026
  • FDA UDI 72775540-72b1-4792-8250-88b539f2cbd4 37 fields · synced May 30, 2026
  • FDA UDI a2989f57-e8a0-4b70-aaa7-c450659dec9d 37 fields · synced May 30, 2026
  • FDA UDI e6a49715-b03b-444a-82be-524314cf513f 37 fields · synced May 30, 2026
  • FDA UDI 3d6ab649-644d-4210-af71-5dfaa82d5419 37 fields · synced May 30, 2026
  • FDA UDI fa67c760-7580-45b3-8c07-156f191215a9 37 fields · synced May 30, 2026
  • FDA UDI 3e757aae-9cba-4dad-b1a5-a239f87caab2 37 fields · synced May 30, 2026
  • FDA UDI ff2b4894-7491-4c49-905b-8af554620f2b 37 fields · synced May 30, 2026
  • FDA UDI b3927416-5123-4298-840d-7e9d9cc3c9a9 37 fields · synced May 30, 2026
  • FDA UDI 73c4b3c5-70d5-42ab-adf6-3d941f588b19 37 fields · synced May 30, 2026
  • FDA UDI 3e4ca550-31ff-46b7-9a4a-72238fa87f2e 37 fields · synced May 30, 2026
  • FDA UDI 00215713-8390-4fbc-9091-1fdcdcf8edbe 37 fields · synced May 30, 2026
  • FDA UDI a9274d60-8811-463d-9cd4-e7fd84272dd2 37 fields · synced May 30, 2026
  • FDA UDI fddc16ab-7b9b-4c80-bd3a-70f4ece73caf 37 fields · synced May 30, 2026
  • FDA UDI 5b264572-5ed0-40bd-ba4f-5623a23cdfac 37 fields · synced May 30, 2026
  • FDA UDI f76d1559-ae7e-4842-b688-ad9c88a07820 37 fields · synced May 30, 2026
  • FDA UDI f659177e-c534-4531-af40-add3a9885bfa 37 fields · synced May 30, 2026
  • FDA UDI 8e13e246-b968-4413-9479-2df8c334eec8 37 fields · synced May 30, 2026
  • FDA UDI 4b81eae8-5963-43bb-ac57-44773f4d0380 37 fields · synced May 30, 2026
  • FDA UDI 2e2e8183-f7f7-4d21-b1fb-cddf58e8d135 37 fields · synced May 30, 2026
  • FDA UDI 27e0b0a1-985e-4726-a600-e10f6d515c54 37 fields · synced May 30, 2026
  • FDA UDI 5ffc7026-6e6b-4b0e-9b2e-c1bd82369d4d 37 fields · synced May 30, 2026
  • FDA UDI 143676be-6f29-42ef-b07e-b8f7fd488a27 37 fields · synced May 30, 2026
  • FDA UDI 16344369-a7ee-4ab0-a5df-7a0ad530ee40 37 fields · synced May 30, 2026
  • FDA UDI 1ce2490f-034e-4759-8065-7ac6bb79b2f4 37 fields · synced May 30, 2026
  • FDA UDI a1803da2-8d31-4576-b49e-68709ed4feaf 37 fields · synced May 30, 2026
  • FDA UDI a4dea96b-bfa8-4ee6-8ffa-6025becf8b93 37 fields · synced May 30, 2026
  • FDA UDI 9bfece9d-c99f-446f-9735-5b22fafcf677 37 fields · synced May 30, 2026
  • FDA UDI e4a3b34b-4cf4-4521-8c3f-cc07e49d9d22 37 fields · synced May 30, 2026
  • FDA UDI 4f694fb0-a99b-48f4-be19-ea4a296a5460 37 fields · synced May 30, 2026
  • FDA UDI d4e084eb-7688-470c-b838-34b446014d6e 37 fields · synced May 30, 2026
  • FDA UDI 343a6ee0-145d-4d3a-b9c0-fa3d5d187720 37 fields · synced May 30, 2026
  • FDA UDI 944e6cbe-c9a1-47c4-9271-d25f804bf263 37 fields · synced May 30, 2026
  • FDA UDI 0cfc1c04-8826-4b57-bb05-41bdaedfbafc 37 fields · synced May 30, 2026
  • FDA UDI 58afcf28-ece0-4dd8-a812-16e3a0eae03a 37 fields · synced May 30, 2026
  • FDA UDI 0a616e7d-a7bc-4604-9cdd-012246d7eb91 37 fields · synced May 30, 2026
  • FDA UDI 763077fa-22e0-4322-944d-b4cf0e0fa51e 37 fields · synced May 30, 2026
  • FDA UDI 5eba53bd-6c6f-4d22-905d-5665b283c0de 37 fields · synced May 30, 2026
  • FDA UDI 68415485-eedb-48a1-b6fc-dde03fa71614 37 fields · synced May 30, 2026
  • FDA UDI 9013a5f0-12f9-4200-82c7-6d8a763ee618 37 fields · synced May 30, 2026
  • FDA UDI fda54da4-8612-4166-9e26-79f466543b34 37 fields · synced May 30, 2026
  • FDA UDI dab8c3a0-f2ef-4e23-8789-5d406abfb648 37 fields · synced May 30, 2026
  • FDA UDI fee6c95e-5862-4a72-bcdd-ef0356306a37 37 fields · synced May 30, 2026
  • FDA UDI 90eafb23-da43-4d81-8678-b16262359051 37 fields · synced May 30, 2026
  • FDA UDI f86df91e-d856-48c9-a79c-c4c3630c8cd8 38 fields · synced May 30, 2026
  • FDA UDI 5ef05ec2-5ebd-47e3-b6fb-ea15d90f92aa 37 fields · synced May 30, 2026
  • FDA UDI fc41c905-4abb-4937-9e19-a3f05a14e2c6 37 fields · synced May 30, 2026
  • FDA UDI a9fd5a52-7a26-4acc-871e-760686544d62 37 fields · synced May 30, 2026
  • FDA UDI b7d76e2a-948a-44d6-9878-dd6a18a86325 37 fields · synced May 30, 2026
  • EUDAMED 5d112a37-5683-4225-abb4-30cc93fe9fc5 61 fields · synced Jun 20, 2026
  • EUDAMED 8760d6c4-2baf-4966-98fa-9512eaf58e72 61 fields · synced Jun 20, 2026
  • EUDAMED 5e4e18d8-58b1-49fe-923f-eaebc67455fb 61 fields · synced Jun 20, 2026
  • EUDAMED 171970cb-238c-4e48-82fe-41c8b7c48cde 61 fields · synced Jul 8, 2026
  • EUDAMED a1d7d433-109b-4755-b1b4-998ecfe6c554 61 fields · synced Jul 8, 2026
  • EUDAMED 1c521a0a-4a0a-4c29-8a3c-2eb3cee24074 61 fields · synced Jul 9, 2026
  • EUDAMED df42084e-d85f-49fd-9d8a-f2fa9b2e6845 61 fields · synced Jul 9, 2026
  • EUDAMED 60825e34-de92-45a4-accc-36cdc7584f57 61 fields · synced Jul 9, 2026
  • EUDAMED 1faccb44-e383-4070-a937-f90e3d8456f4 61 fields · synced Jul 9, 2026
  • EUDAMED 052a9254-ac7c-499a-b249-e355800e5a62 61 fields · synced Jul 9, 2026
  • EUDAMED adc13c6d-792a-4caf-b93c-52182b6bba20 61 fields · synced Jul 9, 2026
  • EUDAMED 8201b99d-e541-4e51-88c6-3b1b476b846f 61 fields · synced Jul 10, 2026
  • EUDAMED eaff693a-0e7f-40a9-b0db-334ccf98be3d 61 fields · synced Jul 10, 2026
  • EUDAMED 872e27f9-0179-4ded-97a6-ec1bf97fd2ec 61 fields · synced Jul 11, 2026
  • EUDAMED 92ac976a-e32d-4328-9860-619f0d275872 61 fields · synced Jul 11, 2026
  • EUDAMED 63182a5f-3589-498a-bb20-633e38bef314 61 fields · synced Jul 11, 2026
  • EUDAMED 56d997dd-3d35-44e5-aea6-482628b210c7 61 fields · synced Jul 11, 2026
  • EUDAMED 77cc9560-1290-4435-aa6c-33c72168a485 61 fields · synced Jul 11, 2026
  • EUDAMED 8cc9f7eb-3216-4f4f-9587-11d50901282b 61 fields · synced Jul 12, 2026
  • EUDAMED 1b35d55d-e557-4b87-9afb-b870ab69040f 61 fields · synced Jul 12, 2026
  • EUDAMED ce6b83bf-4540-40b5-a40e-cd651d9fc0d1 61 fields · synced Jul 12, 2026
  • EUDAMED 3ef2d720-1ed3-48f0-aaea-c568c7371047 61 fields · synced Jul 13, 2026
  • EUDAMED 565eabe7-b505-4feb-b49c-0b93b51c54d8 61 fields · synced Jul 13, 2026
  • EUDAMED f2aec371-53fb-4dc9-8aa5-8c055ad373bd 61 fields · synced Jul 13, 2026
  • EUDAMED 3988aac3-2174-4c5d-9c2b-495de521f299 61 fields · synced Jul 14, 2026
  • EUDAMED f4cf5b63-5ae9-43cd-af76-2abfa5931266 61 fields · synced Jul 14, 2026
  • EUDAMED cca9a11d-96b1-45fa-b134-f6cc0a3aef70 61 fields · synced Jul 14, 2026
  • EUDAMED 59328484-e360-478d-8fe9-edccc0584e3d 61 fields · synced Jul 14, 2026
  • EUDAMED 44f6f5d1-be44-4122-b3f0-a2451f390cd8 61 fields · synced Jul 14, 2026
  • EUDAMED d6ef6fac-615e-46e3-9e5b-0ac2aff27572 61 fields · synced Jul 14, 2026
  • EUDAMED d26be3e5-6b02-4ccf-a885-5a3f91ca8aed 61 fields · synced Jul 14, 2026
  • EUDAMED ae38dccf-b2f1-4d41-8ed6-44f33d87fa79 61 fields · synced Jul 15, 2026
  • EUDAMED a8cdf2f8-0ebc-4faf-a56b-4259baf323c5 61 fields · synced Jul 15, 2026
  • EUDAMED 28fcc2f9-522c-45c8-9bc3-65288cf7287e 61 fields · synced Jul 16, 2026
  • EUDAMED 8b33848c-f3e6-4f04-9f1f-808157eafb0b 61 fields · synced Jul 16, 2026
  • EUDAMED 427b93ec-95cc-45f3-ad2b-fe3dc654bcef 61 fields · synced Jul 16, 2026
  • EUDAMED e85df48c-199a-4b50-bf80-0aadcb7cc7ff 61 fields · synced Jul 17, 2026
  • EUDAMED 4e6f8f31-4d19-4d6d-b3d5-1af2c30447c9 61 fields · synced Jul 18, 2026
  • EUDAMED 6df8be71-95f5-43a7-abc6-15e1ca0b9b51 61 fields · synced Jul 18, 2026
  • EUDAMED 0e7b8761-1eb0-4a25-aced-24170bbc9c7b 61 fields · synced Jul 18, 2026
  • EUDAMED 0897983a-1db5-41d2-b602-591a2c27b885 61 fields · synced Jul 18, 2026
  • EUDAMED d5238abd-1bfb-449f-aedf-5967523c4780 61 fields · synced Jul 19, 2026
  • EUDAMED 202ebbcc-c468-4719-b773-e11caf0747d9 61 fields · synced Jul 19, 2026
  • EUDAMED 550a38f8-362e-404d-92ad-cdbcb9d49848 61 fields · synced Jul 19, 2026
  • EUDAMED e387f53d-968f-4ae6-8999-335f3146e616 61 fields · synced Jul 19, 2026
  • EUDAMED a334d4ec-1312-487b-ad35-03fa06b36d18 61 fields · synced Jul 21, 2026
  • EUDAMED 48df6772-e4d8-404d-9cfb-17c8c17dfd85 61 fields · synced Jul 22, 2026
  • EUDAMED fea6f2de-72b3-4816-a246-7af29b8c864c 61 fields · synced Jul 22, 2026
  • EUDAMED 9d606a05-fcfd-4336-85f8-da9296d9ba73 61 fields · synced Jul 23, 2026
  • EUDAMED 84097c04-f3ee-427e-b4e1-9b1e9682c669 61 fields · synced Jul 24, 2026
  • EUDAMED 01cade51-5d56-4594-8e6d-41d9931a7eec 61 fields · synced Jul 25, 2026
  • EUDAMED 05996418-efa2-4e5b-9abc-e2a7cf862707 61 fields · synced Jul 26, 2026
  • EUDAMED 9861723f-e8c8-4bb8-8a7c-39881af589d7 61 fields · synced Jul 26, 2026
  • EUDAMED 93659c1d-2911-4c61-ae5b-bb1375942310 61 fields · synced Jul 28, 2026
  • EUDAMED 145cea75-6cb3-4a2f-aae3-fccfc5dd7583 61 fields · synced Jul 29, 2026
  • EUDAMED 80f5a44a-3c8b-4a2a-8f1c-3d31653a7328 61 fields · synced Jul 29, 2026
  • EUDAMED db99ffc3-6b0a-4dc8-b138-ba0cf9cc8035 61 fields · synced Jul 31, 2026
  • EUDAMED 9b229235-d805-4621-afdf-b8edabd1c285 61 fields · synced Jul 31, 2026
  • EUDAMED bde3c0b8-097d-42d3-8c13-3271118d1763 61 fields · synced Aug 1, 2026
  • EUDAMED 22b0bb3b-4cbf-415a-ba57-2e0b73e55974 61 fields · synced Aug 1, 2026
  • EUDAMED 1a00e745-2837-4c3c-a4f6-019a35c188a7 61 fields · synced Aug 2, 2026
  • EUDAMED 6a658501-e06b-4717-a34d-50ad1abe1551 61 fields · synced Aug 2, 2026
  • EUDAMED 2ba4576b-4d11-4db3-9a9a-1d0fa0668c11 61 fields · synced Aug 3, 2026
  • EUDAMED 08821b08-e477-42cd-b892-ed46d0bee893 61 fields · synced Aug 3, 2026
  • EUDAMED 9b12c4f1-9f60-4807-99c5-343514ee6694 61 fields · synced Aug 4, 2026
  • EUDAMED 30b63a90-36c1-4c11-8f2c-192f9a9b2b3a 61 fields · synced Sep 17, 2026
  • EUDAMED 304f7f40-4ea2-4442-8b84-68b81a98c893 61 fields · synced Sep 18, 2026