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DeRoyal 89-4539

by Deroyal Industries, 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 Number00749756596527 UDI-DI Date12 Sep 2016ListedStatusListed 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  • Withdrawn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
DeRoyal
Generic name
Angiography kit
Model / reference
89-4539
Primary DI / UDI-DI
00749756596527
FDA product code
OEQ
GMDN term
Angiography kit
Device class
Class II
Regulation number
870.1650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Angiography kit

Other devices from Deroyal Industries, Inc.

See all devices from Deroyal Industries, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Manufacturing date: No