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Corail L981309

by Depuy (Ireland)

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number10603295446859 UDI-DI Date22 Mar 2019ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Corail
Generic Name
Coated femoral stem prosthesis, one-piece
Model / Ref / Catalog
L981309
Primary DI / UDI-DI
10603295446859
510(k) Number
FDA Product Code
LZO, MEH, KWL, KWY
GMDN Term
Coated femoral stem prosthesis, one-piece
Device Class
Class II
Regulation Number
888.3353, 888.3360, 888.3390
GUDID distribution status
In Commercial Distribution

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Category: Coated femoral stem prosthesis, one-piece

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Cleared under the same submission (K192946)

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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