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Helmut Zepf 08.910.13F

by Helmut Zepf Medizintechnik GmbH

Helmut Zepf 08.910.13F is a Class I device made by Helmut Zepf Medizintechnik GmbH, listed in FDA GUDID since 25 Nov 2022 (UDI-DI EZPF0891013F0), 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 NumberEZPF0891013F0 UDI-DI Date25 Nov 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  • Withdrawn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
Bone trephine, reusable
Model / Ref / Catalog
08.910.13F
Description
TREPHINE INSIDE Ø 5,0 MM, SHEATH 2,35 MM X 30 MM LG, 9 TEETH GRADUATION 7/10/13/16, GUIDING PIN
Primary DI / UDI-DI
EZPF0891013F0
FDA product code
HWK
GMDN term
Bone trephine, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone trephine, reusable

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Other devices filed under Bone trephine, reusable.

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Properties

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