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Helmut Zepf 46.040.02OX

by Helmut Zepf Medizintechnik GmbH

Helmut Zepf 46.040.02OX is a Class I device made by Helmut Zepf Medizintechnik GmbH, listed in FDA GUDID since 7 Dec 2022 (UDI-DI EZPF4604002OX0), 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 NumberEZPF4604002OX0 UDI-DI Date7 Dec 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  • Withdrawn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
Helmut Zepf
Generic name
Periosteal elevator, reusable
Model / Ref / Catalog
46.040.02OX
Description
CURETTE, PERIODONTIC, ONYX-COATING TUNNEL.INSTR/CURETTE 2 F.LOWER JAW, BIONIK, VIOLETT, EXCH. INSERTS, D/E
Primary DI / UDI-DI
EZPF4604002OX0
FDA product code
EMS
GMDN term
Periosteal elevator, reusable
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Periosteal elevator, reusable

Other devices from Helmut Zepf Medizintechnik GmbH

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Properties

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