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Donjoy Performance DP163CT04

by Djo, LLC

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 Number00888912164535 UDI-DI Date19 May 2022ListedStatusListed 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  • Withdrawn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
Donjoy Performance
Generic name
Musculoskeletal hot/cold therapy pack, reusable
Model / reference
DP163CT04
Primary DI / UDI-DI
00888912164535
FDA product code
IME
GMDN term
Musculoskeletal hot/cold therapy pack, reusable
Device class
Class I
Regulation number
890.5700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hot/cold therapy pack, reusable

Other devices from Djo, LLC

See all devices from Djo, LLC →

Properties

  • Contains latex
  • Premarket exempt

Other properties (13)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Lot / batch number: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No