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Gore Dualmesh Plus Biomaterial

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 1DLMCP201Ref 1DLMC203ERef 1DLMCP06Ref 1DLMCP12Ref 1DLMC03Ref 1DLMC05Ref 1DLMC09Ref 1DLMCP204Ref 1DLMC06Ref 1DLMC02ERef 1DLMC08Ref 1DLMC08ERef 1DLMCP202Ref 1DLMC09ERef 1DLMCP07Ref 1DLMCP200Ref 1DLMC203Ref 1DLMC202ERef 1DLMC02Ref 1DLMC200ERef 1DLMCP04

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE® DUALMESH® PLUS BIOMATERIAL EUDAMEDFDA UDI
GORE® DUALMESH® Biomaterial EUDAMED
GORE DUALMESH PLUS BIOMATERIAL FDA UDI
GORE® DUALMESH® PLUS BIOMATERIAL HOLES FDA UDI
GORE DUALMESH Biomaterial FDA UDI
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
Device Name
GORE® DUALMESH® PLUS Biomaterial EUDAMED
GORE® DUALMESH® Biomaterial EUDAMED
GORE DUALMESH BIOMATERIAL 7.5cmX10.0cmX1.0mm FDA UDI
GORE DUALMESH BIOMATERIAL 12.0cmX1.0mm Circle FDA UDI
GORE DUALMESH BIOMATERIAL 18.0cmX24.0cmX1.0mm FDA UDI
GORE DUALMESH BIOMATERIAL 10.0cmX15.0cmX1.0mm FDA UDI
GORE DUALMESH BIOMATERIAL 26.0cmX34.0cmX1.0mm FDA UDI
GORE DUALMESH BIOMATERIAL 8.0cmX12.0cmX1.0mm FDA UDI
GORE DUALMESH BIOMATERIAL 20.0cmX30.0cmX2.0mm FDA UDI
Model / Reference
1DLMCP200 EUDAMEDFDA UDI
1DLMC05 EUDAMEDFDA UDI
1DLMCP04 EUDAMEDFDA UDI
1DLMCP06 EUDAMEDFDA UDI
1DLMC09 EUDAMEDFDA UDI
1DLMC06 EUDAMEDFDA UDI
1DLMC03 EUDAMEDFDA UDI
1DLMCP202 EUDAMEDFDA UDI
1DLMCP12 EUDAMEDFDA UDI
1DLMCP07 EUDAMEDFDA UDI
1DLMC08 EUDAMEDFDA UDI
1DLMC02 EUDAMEDFDA UDI
1DLMC203 EUDAMEDFDA UDI
1DLMCP201 EUDAMEDFDA UDI
1DLMCP204 EUDAMEDFDA UDI
1DLMC203E EUDAMED
1DLMC02E EUDAMED
1DLMC08E EUDAMED
1DLMC09E EUDAMED
1DLMC202E EUDAMED
1DLMC200E EUDAMED
1DLMCPH08 FDA UDI
Description
GORE DUALMESH BIOMATERIAL 7.5cmX10.0cmX1.0mm FDA UDI
GORE DUALMESH BIOMATERIAL 12.0cmX1.0mm Circle FDA UDI
GORE DUALMESH BIOMATERIAL 18.0cmX24.0cmX1.0mm FDA UDI
GORE DUALMESH BIOMATERIAL 10.0cmX15.0cmX1.0mm FDA UDI
GORE DUALMESH BIOMATERIAL 26.0cmX34.0cmX1.0mm FDA UDI
GORE DUALMESH BIOMATERIAL 8.0cmX12.0cmX1.0mm FDA UDI
GORE DUALMESH BIOMATERIAL 20.0cmX30.0cmX2.0mm FDA UDI

Identifiers

Catalog Number
1DLMCP200 FDA UDI
1DLMCPH08 FDA UDI
1DLMC05 FDA UDI
1DLMCP04 FDA UDI
1DLMCP06 FDA UDI
1DLMC09 FDA UDI
1DLMC06 FDA UDI
1DLMC03 FDA UDI
1DLMCP202 FDA UDI
1DLMCP12 FDA UDI
1DLMCP07 FDA UDI
1DLMC08 FDA UDI
1DLMC02 FDA UDI
1DLMC203 FDA UDI
1DLMCP201 FDA UDI
1DLMCP204 FDA UDI
Primary DI / UDI-DI
00733132601172 EUDAMEDFDA UDI
00733132600984 EUDAMEDFDA UDI
00733132601110 EUDAMEDFDA UDI
00733132601134 EUDAMEDFDA UDI
00733132601028 EUDAMEDFDA UDI
00733132600991 EUDAMEDFDA UDI
00733132600960 EUDAMEDFDA UDI
00733132601196 EUDAMEDFDA UDI
00733132601165 EUDAMEDFDA UDI
00733132601141 EUDAMEDFDA UDI
00733132601011 EUDAMEDFDA UDI
00733132600953 EUDAMEDFDA UDI
00733132601066 EUDAMEDFDA UDI
00733132601189 EUDAMEDFDA UDI
00733132601219 EUDAMEDFDA UDI
00733132649235 EUDAMED
00733132649006 EUDAMED
00733132649181 EUDAMED
00733132649198 EUDAMED
00733132649228 EUDAMED
00733132649204 EUDAMED
00733132601271 FDA UDI
Basic UDI-DI
B-00733132601189 EUDAMED
B-00733132649235 EUDAMED
B-00733132601134 EUDAMED
B-00733132601165 EUDAMED
B-00733132600960 EUDAMED
B-00733132600984 EUDAMED
B-00733132601028 EUDAMED
B-00733132601219 EUDAMED
B-00733132600991 EUDAMED
B-00733132649006 EUDAMED
B-00733132601011 EUDAMED
B-00733132649181 EUDAMED
B-00733132601196 EUDAMED
B-00733132649198 EUDAMED
B-00733132601141 EUDAMED
B-00733132601172 EUDAMED
B-00733132601066 EUDAMED
B-00733132649228 EUDAMED
B-00733132600953 EUDAMED
B-00733132649204 EUDAMED
B-00733132601110 EUDAMED
510(k) Number
K063435 FDA UDI
K992189 FDA UDI
FDA Product Code
FTL FDA UDI
EMDN Code
P900203 PTFE SURGICAL MESHES EUDAMED
GMDN Term
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI

Classification

Device Class
Class III EUDAMED
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
878.3300 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI
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

Yes

EUDAMEDEUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

Yes

EUDAMEDEUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDIFDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Length — 15 Centimeter FDA UDI
Width — 10 Centimeter FDA UDI
Height — 2 Millimeter FDA UDI
Length — 34 Centimeter FDA UDI
Width — 26 Centimeter FDA UDI
Height — 1.5 Millimeter FDA UDI
Length — 10 Centimeter FDA UDI
Width — 7.5 Centimeter FDA UDI
Height — 1 Millimeter FDA UDI
Length — 19 Centimeter FDA UDI
Width — 15 Centimeter FDA UDI
Length — 24 Centimeter FDA UDI
Width — 18 Centimeter FDA UDI
Length — 12 Centimeter FDA UDI
Width — 8 Centimeter FDA UDI
Width — 6 Centimeter FDA UDI
Width — 20 Centimeter FDA UDI
Length — 30 Centimeter FDA UDI
Width — 12 Centimeter FDA UDI

Gore Dualmesh Plus Biomaterial by W. L. Gore & Associates, Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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 (37)

  • FDA UDI 059a6825-5e40-4470-808a-8bfd5adc1dd2 37 fields · synced Sep 17, 2026
  • FDA UDI 8f094359-aabb-49be-9506-4d69e5a0b5d1 37 fields · synced May 29, 2026
  • FDA UDI 58b4dc48-136b-433a-bfd7-721cab066f4d 37 fields · synced May 29, 2026
  • FDA UDI a4f8ed48-29af-47fb-9e17-197459717ae0 37 fields · synced May 30, 2026
  • FDA UDI 7bdea3cc-9234-4aec-a777-e002a04be5d8 37 fields · synced May 30, 2026
  • FDA UDI 7a2b096e-b8e9-40a6-aef1-297adb20e8c0 37 fields · synced May 30, 2026
  • FDA UDI a8215aae-4bdf-49fb-8d4d-7171e20489bf 37 fields · synced May 30, 2026
  • FDA UDI 524886df-566f-4e59-b32b-69381319f158 37 fields · synced May 30, 2026
  • FDA UDI a0b0dd4d-6df6-4d76-8888-3be723f1cd2f 37 fields · synced May 30, 2026
  • FDA UDI 0a71bfca-ac19-41d2-b9ec-513460a6bc67 37 fields · synced May 30, 2026
  • FDA UDI e0677b59-b26c-4549-81d0-9dd8456c9dc0 37 fields · synced May 30, 2026
  • FDA UDI 86d4bcba-1d73-430d-a8f5-36010441225b 37 fields · synced May 30, 2026
  • FDA UDI 2ff763f9-1288-430f-bf9c-5606afce4f1b 37 fields · synced May 30, 2026
  • FDA UDI 2b6de8d8-321e-4a5a-9d9d-8fed341e92b1 37 fields · synced May 30, 2026
  • FDA UDI 806462af-8e31-44dc-b342-a2dc23203ceb 37 fields · synced May 30, 2026
  • FDA UDI b6c7bfc0-5e03-4612-9578-3d54a7d099d0 37 fields · synced May 30, 2026
  • EUDAMED 88ded54c-1a7e-4766-93ba-7bd8c71e8524 61 fields · synced Jul 9, 2026
  • EUDAMED bf438ab4-5f33-45fa-a239-65286628cca6 61 fields · synced Jul 9, 2026
  • EUDAMED 0282d51d-9984-4c13-b2f2-82c78d082ff8 61 fields · synced Jul 9, 2026
  • EUDAMED 3bf83140-6836-4a79-aae0-91d5ae6b0513 61 fields · synced Jul 11, 2026
  • EUDAMED e77d668a-cad9-43e1-8704-8c48d2ddf460 61 fields · synced Jul 11, 2026
  • EUDAMED 0d4afed0-9703-499d-9b6b-88b1891442de 61 fields · synced Jul 12, 2026
  • EUDAMED 03741435-4916-455c-95d3-4739f20e6348 61 fields · synced Jul 12, 2026
  • EUDAMED 704d9375-e0c1-4f79-b554-d70da8d15467 61 fields · synced Jul 13, 2026
  • EUDAMED 0687d690-f4c5-4b15-9e35-f9df36b7f4ff 61 fields · synced Jul 13, 2026
  • EUDAMED 74c5e019-33f1-4be0-97f1-cfe4bc8091a1 61 fields · synced Jul 13, 2026
  • EUDAMED c796aebf-3b63-4f02-be3e-1489f5a7134b 61 fields · synced Jul 15, 2026
  • EUDAMED d61d1baf-5960-4911-8a55-860b59ad5e4c 61 fields · synced Jul 16, 2026
  • EUDAMED 37eebb60-753f-4b7c-ba72-075cc4ec35b9 61 fields · synced Jul 19, 2026
  • EUDAMED 67f4f53f-e143-41b2-b54e-bf26d7ba55be 61 fields · synced Jul 22, 2026
  • EUDAMED e7043f2c-edad-481a-9f8e-f9776d450c43 61 fields · synced Jul 25, 2026
  • EUDAMED eba9cf53-dacc-43d7-8b14-e78af9ba8c46 61 fields · synced Jul 28, 2026
  • EUDAMED 585941d1-60b8-42a0-8371-adefecf6d8e0 61 fields · synced Aug 2, 2026
  • EUDAMED 3e949e8e-2161-450f-9f53-7b0be404e09d 61 fields · synced Aug 3, 2026
  • EUDAMED eab66e2f-e5b2-42a0-ba13-5766f0410fcb 61 fields · synced Aug 4, 2026
  • EUDAMED 351d4703-4e25-4b0b-ad9d-7a6fcdae7c7b 61 fields · synced Sep 17, 2026
  • EUDAMED 97347646-cb0f-47a2-ab7b-104dd5551e9c 61 fields · synced Sep 17, 2026