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Gia GIA80TMC

by Covidien LP

Part of a family of 12 devices: see the family page

Ref GIA80TMC

Gia GIA80TMC is a device classified as Class IIb in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 10 Jul 2026 (Basic UDI-DI 0763000B00012537L), cleared under FDA 510(k) K231934 on 27 Oct 2023 and listed in FDA GUDID since 19 Mar 2024 (UDI-DI 10884521842687), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231934

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00012537L Basic UDI-DI 10884521842687UDI-DIDate10 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521842687 UDI-DI Date19 Mar 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK231934 Date27 Oct 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00012537L registered 10 Jul 2026 Active
  • FDA 510(k) K231934 decided 27 Oct 2023 Active
  • FDA GUDID UDI-DI 10884521842687 listed 19 Mar 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K231934
  2. Listed FDA GUDID 10884521842687
  3. Registered EUDAMED 0763000B00012537L

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Tri-StapleTM, GIATM EUDAMED
Gia GUDID
Generic name
Surgical staple loading unit, non-cutting
Device name
GIATM Stapler with Tri-StapleTM
Model / reference
GIA80TMC
Primary DI / UDI-DI
10884521842687
Basic UDI-DI
0763000B00012537L
510(k) Number
FDA product code
GDW, GAG
EMDN code
H020201010101 Single patient straight linear staplers with blade for open surgery
GMDN term
Surgical staple loading unit, non-cutting
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4750, 878.4740
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Length — 80 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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.

Related devices

Category: Surgical staple loading unit, non-cutting

Cleared under the same submission (K231934)

Similar devices in this category

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

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)