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UniSyn® Hip System 3441-13642-0

by Consensus Orthopedics, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number00844588012310 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: not 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  • Withdrawn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
UniSyn® Hip System
Generic Name
Press-fit hip femur prosthesis, modular
Model / Ref / Catalog
3441-13642-0
Primary DI / UDI-DI
00844588012310
FDA Product Code
JDI
GMDN Term
Press-fit hip femur prosthesis, modular
Device Class
Class II
Regulation Number
888.3350
GUDID distribution status
Not in Commercial Distribution
Size
Length — 36 Millimeter

Other devices from Consensus Orthopedics, Inc.

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Properties

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

Other properties (7)

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