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Helmut Zepf

FDA UDI

Class I (US FDA UDI)

by Helmut Zepf Medizintechnik GmbH

Identity

Trade Name
HELMUT ZEPF FDA UDI
Generic Name
Syndesmotome FDA UDI
Device Name
GIN-KNIFE FIG. 2, CURVED, Z-SHAPE HANDLE SINGLE-ENDED, M4 X 0,5MM , EXCHANGEABLE FDA UDI
Model / Reference
26.182.39 FDA UDI
Description
GIN-KNIFE FIG. 2, CURVED, Z-SHAPE HANDLE SINGLE-ENDED, M4 X 0,5MM , EXCHANGEABLE FDA UDI

Identifiers

Catalog Number
26.182.39 FDA UDI
Primary DI / UDI-DI
EZPF26182390 FDA UDI
FDA Product Code
EMO FDA UDI
GMDN Term
Syndesmotome FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Syndesmotome

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

Similar devices

Also classified as Syndesmotome.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Helmut Zepf Medizintechnik GmbH

Sources (1)

  • FDA UDI ee073fb6-139b-4f51-a987-70e27e77328e 35 fields · synced Jun 8, 2026