Fisch cutting and preparation jig

FDA UDI

Class I (US FDA UDI)

by Spiggle & Theis Medizintechnik GmbH

Identity

Trade Name: Fisch cutting and preparation jig FDA UDI
Generic Name: Surgical cutting/shaping board, reusable FDA UDI
Device Name: for stapes prostheses with PTFE base 0.6 mm FDA UDI
Model / Reference: 10-738-06 FDA UDI
Description: for stapes prostheses with PTFE base 0.6 mm FDA UDI

Identifiers

Catalog Number: 10-738-06 FDA UDI
Primary DI / UDI-DI: 04250676732354 FDA UDI
FDA Product Code: NNR FDA UDI
GMDN Term: Surgical cutting/shaping board, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.3540 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical cutting/shaping board, reusable

Fisch cutting and preparation jig by Spiggle & Theis 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: Spiggle & Theis Medizintechnik GmbH

Sources (1)

FDA UDI a0163e06-0108-4823-accd-75525886b30f 35 fields · synced May 30, 2026