Helmut Zepf

FDA UDI

Class I (US FDA UDI)

by Helmut Zepf Medizintechnik GmbH

Identity

Trade Name: HELMUT ZEPF FDA UDI
Generic Name: Bone trephine, reusable FDA UDI
Device Name: TREPHINE INSIDE Ø 6 MM, 2,35X30 MM, 11 TEETH, GRADUATION 7/10/13 > SHORTER BODY 13,5 MM FDA UDI
Model / Reference: 08.910.08S FDA UDI
Description: TREPHINE INSIDE Ø 6 MM, 2,35X30 MM, 11 TEETH, GRADUATION 7/10/13 > SHORTER BODY 13,5 MM FDA UDI

Identifiers

Catalog Number: 08.910.08S FDA UDI
Primary DI / UDI-DI: EZPF0891008S0 FDA UDI
FDA Product Code: HWK FDA UDI
GMDN Term: Bone trephine, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone trephine, reusable

Helmut Zepf by Helmut Zepf Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Helmut Zepf Medizintechnik GmbH

Sources (1)

FDA UDI 007da77c-8704-441b-869b-0d51319c211a 35 fields · synced May 31, 2026