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Durasul® 4377-28-057

by Zimmer, Inc.

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 Number00889024169203 UDI-DI Date23 Oct 2017ListedStatusListed 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  • Withdrawn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
Durasul®
Generic Name
Non-constrained polyethylene acetabular liner
Model / Ref / Catalog
4377-28-057
Primary DI / UDI-DI
00889024169203
FDA Product Code
JDI, LPH
GMDN Term
Non-constrained polyethylene acetabular liner
Device Class
Class II
Regulation Number
888.3350, 888.3358
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 28 Millimeter
Outer Diameter — 57 Millimeter

Related devices

Category: Non-constrained polyethylene acetabular liner

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

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