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Proximate PXR35

by Ethicon Endo-Surgery, LLC

Ref PXR35

Proximate PXR35 is a device classified as Class IIa in the EU and Class I in the US made by Ethicon Endo-Surgery, LLC, registered in EUDAMED on 9 Mar 2026 (Basic UDI-DI B-USMF000013107000069MX) and listed in FDA GUDID since 15 Jul 2016 (UDI-DI D-USMF000013107000069MX), active as of 23 Oct 2026.

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

CE MDD

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-USMF000013107000069MX Basic UDI-DI D-USMF000013107000069MXUDI-DIDate9 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-USMF000013107000069MX UDI-DI Date15 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-USMF000013107000069MX registered 9 Mar 2026 Active
  • FDA GUDID UDI-DI D-USMF000013107000069MX listed 15 Jul 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-USMF000013107000069MX
  2. Registered EUDAMED B-USMF000013107000069MX

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Proximate
Generic name
Skin stapler/staple, non-bioabsorbable
Model / Ref / Catalog
PXR35
Primary DI / UDI-DI
D-USMF000013107000069MX EUDAMED
10705036002666 GUDID
Basic UDI-DI
B-USMF000013107000069MX
FDA product code
GDT
EMDN code
H02010101 Skin staplers, single-use
GMDN term
Skin stapler/staple, non-bioabsorbable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4760
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-USMF000013107000069MX
GUDID
10705036002666
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-USMF000013107000069MX; FDA GUDID lists 10705036002666), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Skin stapler/staple, non-bioabsorbable

Similar devices in this category

Other devices filed under SKIN STAPLERS, SINGLE-USE.

Other devices from Ethicon Endo-Surgery, LLC

See all devices from Ethicon Endo-Surgery, LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)