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DeRoyal 53-1958

by Deroyal Industries, Inc.

DeRoyal 53-1958 is a Class II device made by Deroyal Industries, Inc., listed in FDA GUDID since 17 Oct 2019 (UDI-DI 00749756997379), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00749756997379 UDI-DI Date17 Oct 2019ListedStatusListed GUDID: in commercial distribution

Official records

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  • Withdrawn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
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog
53-1958
Primary DI / UDI-DI
00749756997379
FDA product code
OHD
GMDN term
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
Device class
Class II
Regulation number
884.1720
GUDID distribution status
In Commercial Distribution

Related devices

Category: Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

Other devices from Deroyal Industries, Inc.

See all devices from Deroyal Industries, Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)