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Fentex

FDA UDI

Class I (US FDA UDI)

by FENTEX medical GmbH

Identity

Trade Name
FENTEX FDA UDI
Generic Name
Craniofacial rongeur, reusable FDA UDI
Device Name
Sphenoid Punch by FS-Kerrison 90° upbiting, detachable WL 18 cm, width 1 mm FDA UDI
Model / Reference
413001FX FDA UDI
Description
Sphenoid Punch by FS-Kerrison 90° upbiting, detachable WL 18 cm, width 1 mm FDA UDI

Identifiers

Catalog Number
413001FX FDA UDI
Primary DI / UDI-DI
04250407733346 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
Craniofacial rongeur, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 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: Craniofacial rongeur, reusable

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Similar devices

Also classified as Craniofacial rongeur, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FENTEX medical GmbH

Sources (1)

  • FDA UDI 099a6971-5069-4074-bb1f-6fa7bf853538 35 fields · synced Jul 4, 2026