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Proximate

by Ethicon Endo-Surgery, LLC 21 variants

Part of a family of 7 devices: see the family page

Ref TCT75

Proximate (TCT75) is a device classified as Class IIb in the EU and Class II in the US made by Ethicon Endo-Surgery, LLC, registered in EUDAMED on 6 Feb 2026 (Basic UDI-DI 0705036a000476Y) and listed in FDA GUDID since 24 Aug 2015 (UDI-DI 10705036013150), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705036a000476Y Basic UDI-DI 10705036013150UDI-DIDate6 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705036013150 UDI-DI Date24 Aug 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0705036a000476Y registered 6 Feb 2026 Active
  • FDA GUDID UDI-DI 10705036013150 listed 24 Aug 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10705036013150
  2. Registered EUDAMED 0705036a000476Y

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Open-surgery manual linear cutting stapler, single-use
Model / Ref / Catalog
TCT75
Primary DI / UDI-DI
10705036013150
Basic UDI-DI
0705036a000476Y
FDA product code
GDW
EMDN code
H020201010101 Single patient straight linear staplers with blade for open surgery
GMDN term
Open-surgery manual linear cutting stapler, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4750
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000013107
Authorised representative
Johnson & Johnson Medical GmbH DE-AR-000007712

Related devices

Category: Open-surgery manual linear cutting stapler, single-use

Similar devices in this category

Other devices filed under SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY.

Other devices from Ethicon Endo-Surgery, LLC

See all devices from Ethicon Endo-Surgery, LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)