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S-Rom 56-3618

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 Number10603295178224 UDI-DI Date24 Mar 2015ListedStatusListed 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  • Withdrawn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
S-Rom
Generic Name
Uncoated hip femur prosthesis, modular
Model / Ref / Catalog
56-3618, 563618
Primary DI / UDI-DI
10603295178224
FDA Product Code
MRA, JDI
GMDN Term
Uncoated hip femur prosthesis, modular
Device Class
Class III
Regulation Number
888.3350
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Uncoated hip femur prosthesis, modular

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