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Retractor Apfel 10-5516

by W.H. Holden, Inc.

Retractor Apfel 10-5516 is a Class I device made by W.H. Holden, Inc., listed in FDA GUDID since 1 Nov 2023 (UDI-DI D9281055160), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD9281055160 UDI-DI Date1 Nov 2023ListedStatusListed 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  • Withdrawn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
Retractor Apfel
Generic name
Dental cheek retractor, professional, reusable
Model / reference
10-5516
Primary DI / UDI-DI
D9281055160
FDA product code
GAD
GMDN term
Dental cheek retractor, professional, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental cheek retractor, professional, reusable

Other devices from W.H. Holden, Inc.

See all devices from W.H. Holden, Inc. →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)