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Aequalis™ Flex Revive™ ARS916903

by Tornier, 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 Number00846832074105 UDI-DI Date13 Jul 2020ListedStatusListed 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  • Withdrawn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
Aequalis™ Flex Revive™
Generic Name
Humeral stem prosthesis trial, reusable
Model / Ref / Catalog
ARS916903
Primary DI / UDI-DI
00846832074105
FDA Product Code
KWS, PHX, HSD
GMDN Term
Humeral stem prosthesis trial, reusable
Device Class
Class II
Regulation Number
888.3660, 888.3690
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 9 Millimeter
Length — 120 Millimeter

Related devices

Category: Humeral stem prosthesis trial, reusable

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No