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Proximate TLC75

by Ethicon Endo-Surgery, LLC

Ref TLC75

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705036a000476Y Basic UDI-DI 10705036013211UDI-DIDate6 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705036013211 UDI-DI Date24 Aug 2015ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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

Trade Name
Proximate
Generic Name
Open-surgery manual linear cutting stapler, single-use
Model / Ref / Catalog
TLC75
Primary DI / UDI-DI
10705036013211
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 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

Other devices from Ethicon Endo-Surgery, LLC

See all devices from Ethicon Endo-Surgery, LLC →

Properties

  • Sterile
  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No