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Co-Axial Introducer Needle

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref MCXS1415LXRef MCXS1412SXRef MCXS2016AYRef MCXS1616TXRef MCXS1810BPRef MCXS1809LXRef MCXS1420LXRef MCXS1820TXRef MCXS1410AXRef MCXS1610BPRef MCXS2010AYRef MCXS1608SXRef MCXS1810AXRef MCXS1415LXMRef MCXS1816TXRef MCXS1410TXRef MCXS1810BPURef MCXS1410TXMRef MCXS1612SXRef MCXS1615LXRef MCXS2020LYRef MCXS1820LXRef MCXS1409LXMRef MCXS1616TXMRef MCXS1616AXRef MCXS1816MXRef MCXS1820BPURef MCXS1416TXRef MCXS2016TYRef MCXS1615BPRef MCXS1820BPRef MCXS1820MXRef MCXS1815BPURef MCXS1610MX

by Argon Medical Devices, Inc.

Identity

Trade Name
Co-Axial Introducer Needle EUDAMEDFDA UDI
Co-Axial Introducer EUDAMED
Generic Name
Needle guide, single-use FDA UDI
Device Name
Co-Axial Introducer Needle EUDAMED
Co-Axial Introducer Needle 17ga x 6.8cm FDA UDI
Co-Axial Introducer Needle 17ga x 9.9cm FDA UDI
Co-Axial Introducer Needle 15ga x 11.8cm FDA UDI
Co-Axial Introducer Needle 19ga x 11.4cm FDA UDI
Co-Axial Introducer Needle 13ga x 4.6cm FDA UDI
Co-Axial Introducer Needle 19ga x 10.9cm FDA UDI
Co-Axial Introducer Needle 15ga x 11.1cm FDA UDI
Co-Axial Introducer Needle 15ga x 10.6cm FDA UDI
Co-Axial Introducer Needle 15ga x 7.5cm FDA UDI
Co-Axial Introducer Needle 17ga x 15.1cm FDA UDI
Co-Axial Introducer Needle 19ga x 15.2cm FDA UDI
Co-Axial Introducer Needle 16ga x 16.8cm FDA UDI
Co-Axial Introducer Needle 13ga x 14.9cm FDA UDI
Co-Axial Introducer Needle 16ga x 11.8cm FDA UDI
Co-Axial Introducer Needle 17ga x 14.3cm FDA UDI
Co-Axial Introducer Needle 17ga x 11.1cm FDA UDI
Co-Axial Introducer Needle 17ga x 3.9cm FDA UDI
Co-Axial Introducer Needle 17ga x 16.8cm FDA UDI
Co-Axial Introducer Needle 13ga x 9.9cm FDA UDI
Co-Axial Introducer Needle 13ga x 11.1cm FDA UDI
Co-Axial Introducer Needle 17ga x 10.3cm FDA UDI
Co-Axial Introducer Needle 19ga x 4.9cm FDA UDI
Co-Axial Introducer Needle 15ga x 3.5cm FDA UDI
Co-Axial Introducer Needle 15ga x 4.3cm FDA UDI
Co-Axial Introducer Needle 13ga x 5.1cm FDA UDI
Co-Axial Introducer Needle 17ga x 14.9cm FDA UDI
Co-Axial Introducer Needle 17ga x 4.6cm FDA UDI
Co-Axial Introducer Needle 15ga x 6.8cm FDA UDI
Co-Axial Introducer Needle 16ga x 6.8cm FDA UDI
Co-Axial Introducer Needle 13ga x 7.5cm FDA UDI
Co-Axial Introducer Needle 13ga x 3.9cm FDA UDI
Co-Axial Introducer Needle 15ga x 9.9cm FDA UDI
Model / Reference
MCXS1810BP EUDAMEDFDA UDI
MCXS1615BP EUDAMEDFDA UDI
MCXS2016TY EUDAMEDFDA UDI
MCXS1410AX EUDAMEDFDA UDI
MCXS2016AY EUDAMEDFDA UDI
MCXS1616TX EUDAMEDFDA UDI
MCXS1616AX EUDAMEDFDA UDI
MCXS1612SX EUDAMEDFDA UDI
MCXS1820TX EUDAMEDFDA UDI
MCXS2020LY EUDAMEDFDA UDI
MCXS1820BPU EUDAMEDFDA UDI
MCXS1420LX EUDAMEDFDA UDI
MCXS1616TXM EUDAMEDFDA UDI
MCXS1815BPU EUDAMEDFDA UDI
MCXS1820MX EUDAMEDFDA UDI
MCXS1816TX EUDAMEDFDA UDI
MCXS1809LX EUDAMEDFDA UDI
MCXS1820BP EUDAMEDFDA UDI
MCXS1415LXM EUDAMEDFDA UDI
MCXS1416TX EUDAMEDFDA UDI
MCXS1816MX EUDAMEDFDA UDI
MCXS2010AY EUDAMEDFDA UDI
MCXS1608SX EUDAMEDFDA UDI
MCXS1610MX EUDAMEDFDA UDI
MCXS1410TX EUDAMEDFDA UDI
MCXS1820LX EUDAMEDFDA UDI
MCXS1410TXM EUDAMEDFDA UDI
MCXS1810AX EUDAMEDFDA UDI
MCXS1610BP EUDAMEDFDA UDI
MCXS1810BPU EUDAMEDFDA UDI
MCXS1412SX EUDAMEDFDA UDI
MCXS1415LX EUDAMEDFDA UDI
MCXS1409LXM EUDAMEDFDA UDI
MCXS1615LX EUDAMEDFDA UDI
MCXS1815LX FDA UDI
Description
Co-Axial Introducer Needle 17ga x 6.8cm FDA UDI
Co-Axial Introducer Needle 17ga x 9.9cm FDA UDI
Co-Axial Introducer Needle 15ga x 11.8cm FDA UDI
Co-Axial Introducer Needle 19ga x 11.4cm FDA UDI
Co-Axial Introducer Needle 13ga x 4.6cm FDA UDI
Co-Axial Introducer Needle 19ga x 10.9cm FDA UDI
Co-Axial Introducer Needle 15ga x 11.1cm FDA UDI
Co-Axial Introducer Needle 15ga x 10.6cm FDA UDI
Co-Axial Introducer Needle 15ga x 7.5cm FDA UDI
Co-Axial Introducer Needle 17ga x 15.1cm FDA UDI
Co-Axial Introducer Needle 19ga x 15.2cm FDA UDI
Co-Axial Introducer Needle 16ga x 16.8cm FDA UDI
Co-Axial Introducer Needle 13ga x 14.9cm FDA UDI
Co-Axial Introducer Needle 16ga x 11.8cm FDA UDI
Co-Axial Introducer Needle 17ga x 14.3cm FDA UDI
Co-Axial Introducer Needle 17ga x 11.1cm FDA UDI
Co-Axial Introducer Needle 17ga x 3.9cm FDA UDI
Co-Axial Introducer Needle 17ga x 16.8cm FDA UDI
Co-Axial Introducer Needle 13ga x 9.9cm FDA UDI
Co-Axial Introducer Needle 13ga x 11.1cm FDA UDI
Co-Axial Introducer Needle 17ga x 10.3cm FDA UDI
Co-Axial Introducer Needle 19ga x 4.9cm FDA UDI
Co-Axial Introducer Needle 15ga x 3.5cm FDA UDI
Co-Axial Introducer Needle 15ga x 4.3cm FDA UDI
Co-Axial Introducer Needle 13ga x 5.1cm FDA UDI
Co-Axial Introducer Needle 17ga x 14.9cm FDA UDI
Co-Axial Introducer Needle 17ga x 4.6cm FDA UDI
Co-Axial Introducer Needle 15ga x 6.8cm FDA UDI
Co-Axial Introducer Needle 16ga x 6.8cm FDA UDI
Co-Axial Introducer Needle 13ga x 7.5cm FDA UDI
Co-Axial Introducer Needle 13ga x 3.9cm FDA UDI
Co-Axial Introducer Needle 15ga x 9.9cm FDA UDI

Identifiers

Catalog Number
MCXS1810BP FDA UDI
MCXS1815LX FDA UDI
MCXS1615BP FDA UDI
MCXS2016TY FDA UDI
MCXS1410AX FDA UDI
MCXS2016AY FDA UDI
MCXS1616TX FDA UDI
MCXS1616AX FDA UDI
MCXS1612SX FDA UDI
MCXS1820TX FDA UDI
MCXS2020LY FDA UDI
MCXS1820BPU FDA UDI
MCXS1420LX FDA UDI
MCXS1616TXM FDA UDI
MCXS1815BPU FDA UDI
MCXS1820MX FDA UDI
MCXS1816TX FDA UDI
MCXS1809LX FDA UDI
MCXS1820BP FDA UDI
MCXS1415LXM FDA UDI
MCXS1416TX FDA UDI
MCXS1816MX FDA UDI
MCXS2010AY FDA UDI
MCXS1608SX FDA UDI
MCXS1610MX FDA UDI
MCXS1410TX FDA UDI
MCXS1820LX FDA UDI
MCXS1410TXM FDA UDI
MCXS1810AX FDA UDI
MCXS1610BP FDA UDI
MCXS1810BPU FDA UDI
MCXS1412SX FDA UDI
MCXS1415LX FDA UDI
MCXS1409LXM FDA UDI
MCXS1615LX FDA UDI
Primary DI / UDI-DI
20886333002195 EUDAMED
20886333002317 EUDAMED
20886333002102 EUDAMED
20886333002492 EUDAMED
20886333002447 EUDAMED
20886333002560 EUDAMED
20886333002232 EUDAMED
20886333001969 EUDAMED
20886333002355 EUDAMED
20886333002294 EUDAMED
20886333001914 EUDAMED
20886333002225 EUDAMED
20886333002454 EUDAMED
20886333225693 EUDAMED
20886333002010 EUDAMED
20886333002324 EUDAMED
20886333225594 EUDAMED
20886333224788 EUDAMED
20886333002218 EUDAMED
20886333002539 EUDAMED
20886333002157 EUDAMED
20886333001983 EUDAMED
20886333225686 EUDAMED
20886333224757 EUDAMED
20886333002522 EUDAMED
20886333002034 EUDAMED
20886333225617 EUDAMED
20886333002256 EUDAMED
20886333002133 EUDAMED
20886333002546 EUDAMED
20886333001990 EUDAMED
20886333001976 EUDAMED
20886333225600 EUDAMED
20886333002171 EUDAMED
00886333002443 FDA UDI
00886333002276 FDA UDI
00886333002542 FDA UDI
00886333002139 FDA UDI
00886333002351 FDA UDI
00886333002108 FDA UDI
00886333002498 FDA UDI
00886333002528 FDA UDI
00886333002214 FDA UDI
00886333001965 FDA UDI
00886333002153 FDA UDI
00886333225613 FDA UDI
00886333002238 FDA UDI
00886333224753 FDA UDI
00886333225606 FDA UDI
00886333001972 FDA UDI
00886333002016 FDA UDI
00886333002566 FDA UDI
00886333001996 FDA UDI
00886333225699 FDA UDI
00886333002252 FDA UDI
00886333002030 FDA UDI
00886333001910 FDA UDI
00886333002221 FDA UDI
00886333002177 FDA UDI
00886333002320 FDA UDI
00886333001989 FDA UDI
00886333224784 FDA UDI
00886333002450 FDA UDI
00886333002290 FDA UDI
00886333225590 FDA UDI
00886333002313 FDA UDI
00886333002191 FDA UDI
00886333225682 FDA UDI
00886333002535 FDA UDI
Basic UDI-DI
B-20886333002195 EUDAMED
B-20886333002317 EUDAMED
B-20886333002102 EUDAMED
B-20886333002492 EUDAMED
B-20886333002447 EUDAMED
B-20886333002560 EUDAMED
B-20886333002232 EUDAMED
B-20886333001969 EUDAMED
B-20886333002355 EUDAMED
B-20886333002294 EUDAMED
B-20886333001914 EUDAMED
B-20886333002225 EUDAMED
B-20886333002454 EUDAMED
B-20886333225693 EUDAMED
B-20886333002010 EUDAMED
B-20886333002324 EUDAMED
B-20886333225594 EUDAMED
B-20886333224788 EUDAMED
B-20886333002218 EUDAMED
B-20886333002539 EUDAMED
B-20886333002157 EUDAMED
B-20886333001983 EUDAMED
B-20886333225686 EUDAMED
B-20886333224757 EUDAMED
B-20886333002522 EUDAMED
B-20886333002034 EUDAMED
B-20886333225617 EUDAMED
B-20886333002256 EUDAMED
B-20886333002133 EUDAMED
B-20886333002546 EUDAMED
B-20886333001990 EUDAMED
B-20886333001976 EUDAMED
B-20886333225600 EUDAMED
B-20886333002171 EUDAMED
FDA Product Code
KNW FDA UDI
EMDN Code
A010299 BIOPSY NEEDLES AND KITS - OTHER EUDAMED
GMDN Term
Needle guide, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.1075 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

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

Category: Needle guide, single-use

Co-Axial Introducer Needle by Argon Medical Devices, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Needle guide, single-use.

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
Argon Medical Devices, Inc.

Sources (69)

  • FDA UDI e5821398-3c5c-4447-83e8-2f5dd573e025 36 fields · synced Aug 4, 2026
  • FDA UDI 3b77320a-58a2-4054-a824-9bce89b8ee54 36 fields · synced May 24, 2026
  • FDA UDI d08c1e25-88ad-4453-b7aa-8a622838bb3e 36 fields · synced May 24, 2026
  • FDA UDI baf90a7e-cc8a-4e16-bafc-8f9c7c66152d 36 fields · synced May 25, 2026
  • FDA UDI d386340c-9471-4c6f-a499-7efe2b69fc69 36 fields · synced May 27, 2026
  • FDA UDI 36c0010c-94b4-4a2c-a775-73a29cdfe3ad 36 fields · synced May 27, 2026
  • FDA UDI 2d264d2e-cf9b-49bd-a02c-2f6970ca633a 36 fields · synced May 29, 2026
  • FDA UDI b2edd503-69c0-4c4c-b9ce-89570d146a47 36 fields · synced May 30, 2026
  • FDA UDI c37a6d6c-cd74-4d89-a35d-f1fa7b702ce7 36 fields · synced May 30, 2026
  • FDA UDI 68767769-5d66-4403-a8b6-115a6fd9e62e 36 fields · synced May 30, 2026
  • FDA UDI 6e0ff4ca-8088-4f14-9173-102dee351cd3 36 fields · synced May 30, 2026
  • FDA UDI 9ddb72df-67a3-4104-907c-4979848c4934 37 fields · synced May 30, 2026
  • FDA UDI bc73cf30-3c69-437c-9681-1c1ba445f962 36 fields · synced May 30, 2026
  • FDA UDI cb551169-653f-4d49-942a-4b95b90c2a1e 37 fields · synced May 30, 2026
  • FDA UDI c3581e51-3ecd-49ea-99be-9bb291e1562f 37 fields · synced May 30, 2026
  • FDA UDI 7a7b63de-b1d4-4932-8a54-7e1919fa4296 37 fields · synced May 30, 2026
  • FDA UDI 1003135c-859d-4a8f-be7d-0b3c5f725fc3 36 fields · synced May 30, 2026
  • FDA UDI ed0e756d-3b07-4854-b618-2d9b26fc1323 36 fields · synced May 30, 2026
  • FDA UDI ea02a318-3d3f-4f2c-871c-4232046f9d39 36 fields · synced May 30, 2026
  • FDA UDI 9efae1c9-6b72-4db8-bbfc-576cf18afe1a 37 fields · synced May 30, 2026
  • FDA UDI 902a8a95-58f7-4544-b767-716af2eb6336 36 fields · synced May 30, 2026
  • FDA UDI 7013ca32-1f38-4d7a-a77d-bcb1b36f6b70 36 fields · synced May 30, 2026
  • FDA UDI 5b79f991-e3c3-4e1a-a42f-2f9ac1721e09 36 fields · synced May 30, 2026
  • FDA UDI 489c73dd-b6c6-4cc6-9c52-2c57b06adeeb 36 fields · synced May 30, 2026
  • FDA UDI 0bf7615e-57ce-4190-b0d1-e58c8ee13197 36 fields · synced May 30, 2026
  • FDA UDI f08fb794-92d7-4456-9ff2-0d608febf4d3 36 fields · synced May 30, 2026
  • FDA UDI a41f145a-fc83-40dc-b1ae-2fde5e16f0fd 36 fields · synced May 30, 2026
  • FDA UDI b6dfdacc-0909-42a2-9815-f5e9b4dfe4f3 37 fields · synced May 30, 2026
  • FDA UDI 082d7aed-fae8-4321-bf79-d3bbec1e24f4 36 fields · synced May 30, 2026
  • FDA UDI be98d85d-cd56-4d7e-bb56-6e087df06542 36 fields · synced May 30, 2026
  • FDA UDI a4ec9c0d-7eb7-4ebf-b88e-07329df6f08e 37 fields · synced May 30, 2026
  • FDA UDI 825cefc3-384c-4eb8-bdaf-0e8decc155cb 36 fields · synced May 30, 2026
  • FDA UDI e447d9ed-9530-4333-b164-7cd2ee9921b6 36 fields · synced May 30, 2026
  • FDA UDI deb98e80-a396-4779-83e6-406b7bb84226 37 fields · synced May 30, 2026
  • FDA UDI 14e11fa6-a28e-4bce-a438-ad9b923f79cd 36 fields · synced May 30, 2026
  • EUDAMED de7d990a-fce1-45c6-b8e4-82531793f5db 61 fields · synced Jun 20, 2026
  • EUDAMED faadb474-4cfa-491a-be44-fb0c2b9f3690 61 fields · synced Jun 20, 2026
  • EUDAMED ac2a62e4-1cb1-4ed2-8dd5-3f68bb13115d 61 fields · synced Jun 20, 2026
  • EUDAMED 9a2ba58c-d96d-413c-b3cb-b13d515b9af6 61 fields · synced Jul 9, 2026
  • EUDAMED 57fe966d-5722-452f-9978-e491e0d9cf0b 61 fields · synced Jul 9, 2026
  • EUDAMED 0f73d256-eb74-40b7-b66b-66aefeb13a19 61 fields · synced Jul 9, 2026
  • EUDAMED 4f5332da-791a-41f4-bc47-6c0ef288f4e8 61 fields · synced Jul 10, 2026
  • EUDAMED 91da0f4b-a93e-4c1e-9f1f-dc7d831a8d34 61 fields · synced Jul 10, 2026
  • EUDAMED e42273f9-cf48-44a3-966c-3eb92570ee18 61 fields · synced Jul 10, 2026
  • EUDAMED d9b40682-7b1a-4039-a1f6-f2a06dfc683e 61 fields · synced Jul 10, 2026
  • EUDAMED 9cb0f569-0495-4fb1-b56c-d5ce00a712ef 61 fields · synced Jul 10, 2026
  • EUDAMED f52bcd26-d680-4b69-8232-42fd7b0fdf25 61 fields · synced Jul 12, 2026
  • EUDAMED 190147e5-2e91-4e66-a53f-9f4a200496dd 61 fields · synced Jul 12, 2026
  • EUDAMED a54433ec-7462-4b16-9b58-e559c1b8a8dc 61 fields · synced Jul 13, 2026
  • EUDAMED 8a0fcbd2-abcf-4c62-9761-b5a435638d94 61 fields · synced Jul 14, 2026
  • EUDAMED cf6169c7-2d1e-4b60-958d-c7d761588e2e 61 fields · synced Jul 16, 2026
  • EUDAMED 07015ce1-6994-460c-84a4-ed65696d4db8 61 fields · synced Jul 17, 2026
  • EUDAMED 6938f666-6b8f-4391-9f01-14235a377b13 61 fields · synced Jul 17, 2026
  • EUDAMED d2d88785-ac73-4162-a3f8-550381ab1a87 61 fields · synced Jul 19, 2026
  • EUDAMED 9044255a-f72a-4a4b-b120-6eef33cb7e98 61 fields · synced Jul 19, 2026
  • EUDAMED 5de0a2c6-652c-4a19-9260-f776589ccd0e 61 fields · synced Jul 22, 2026
  • EUDAMED 48845a0a-739e-48e1-b54f-ebde319e81fa 61 fields · synced Jul 22, 2026
  • EUDAMED 8492c4d9-e631-4464-9cfd-0b7f3b7d1e9b 61 fields · synced Jul 22, 2026
  • EUDAMED e8423a94-6c8a-493b-b34d-b33577fdc5a2 61 fields · synced Jul 23, 2026
  • EUDAMED 0fe3a774-f2b9-4d6b-ae18-cfe5f946207f 61 fields · synced Jul 27, 2026
  • EUDAMED 78da9e09-5cb9-4b0b-ad60-64e1ee830653 61 fields · synced Jul 27, 2026
  • EUDAMED 346b2183-9282-4332-b402-452ddc6ee114 61 fields · synced Jul 28, 2026
  • EUDAMED 8aee48ac-4f9c-4fd4-a4ca-becf04df0528 61 fields · synced Jul 29, 2026
  • EUDAMED 8c8e056c-8970-452d-bac8-3d44e6e52fad 61 fields · synced Jul 31, 2026
  • EUDAMED aa776a52-b6f1-4d80-8424-dce30cc9d5bc 61 fields · synced Jul 31, 2026
  • EUDAMED 18416039-5bf9-421d-8da4-266de8145077 61 fields · synced Jul 31, 2026
  • EUDAMED cf5c0988-5c7a-43c4-a738-1c6e44b8037a 61 fields · synced Aug 1, 2026
  • EUDAMED 3bb9208d-8bbb-4095-b089-448c975452a5 61 fields · synced Aug 3, 2026
  • EUDAMED ed2e0397-0e75-4bc5-bcfa-1c6174a77508 61 fields · synced Aug 4, 2026