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OMNI Interface Acetabular System H5-54436

by OMNIlife science, Inc.

OMNI Interface Acetabular System H5-54436 is a Class II device made by OMNIlife science, Inc., listed in FDA GUDID since 27 Nov 2015 (UDI-DI 00841690120018), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841690120018 UDI-DI Date27 Nov 2015ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
OMNI Interface Acetabular System
Generic name
Non-constrained polyethylene acetabular liner
Model / Ref / Catalog
H5-54436
Primary DI / UDI-DI
00841690120018
FDA product code
LZO, MEH, LPH
GMDN term
Non-constrained polyethylene acetabular liner
Device class
Class II
Regulation number
888.3353, 888.3358
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: Non-constrained polyethylene acetabular liner

Other devices from OMNIlife science, Inc.

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Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)