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Global Global Unite 1100-08-800

by Depuy (Ireland)

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10603295523406 UDI-DI Date30 Sep 2021ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Global Global Unite
Generic Name
Coated shoulder humeral stem prosthesis
Model / Ref / Catalog
1100-08-800, 110008800
Primary DI / UDI-DI
10603295523406
FDA Product Code
PHX, KWS, HSD
GMDN Term
Coated shoulder humeral stem prosthesis
Device Class
Class II
Regulation Number
888.3660, 888.3690
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Coated shoulder humeral stem prosthesis

Other devices from Depuy (Ireland)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No