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Aequalis Reversed DWE043

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 Number03700386936432 UDI-DI Date16 Oct 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  • Withdrawn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
Aequalis Reversed
Generic Name
Total reverse shoulder prosthesis
Model / Ref / Catalog
DWE043
Primary DI / UDI-DI
03700386936432
FDA Product Code
HSD, KWS, PHX
GMDN Term
Total reverse shoulder prosthesis
Device Class
Class II
Regulation Number
888.3690, 888.3660
GUDID distribution status
In Commercial Distribution
Size
Length — 210 Millimeter
Outer Diameter — 6.5 Millimeter

Related devices

Category: Total reverse shoulder prosthesis

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial 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
  • Lot / Batch Number: No
  • Manufacturing Date: No