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Aequalis™ Long Humeral Nail DHN5797

by Tornier, 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 Number00846832011940 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  • Withdrawn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
Aequalis™ Long Humeral Nail
Generic Name
Arthrodesis intramedullary nail, non-distracting
Model / Reference
DHN5797
Primary DI / UDI-DI
00846832011940
FDA Product Code
HSB
GMDN Term
Arthrodesis intramedullary nail, non-distracting
Device Class
Class II
Regulation Number
888.3020
GUDID distribution status
Not in Commercial Distribution
Size
Length — 250 Millimeter
Outer Diameter — 7 Millimeter

Related devices

Category: Arthrodesis intramedullary nail, non-distracting

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