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Unidrive

FDA UDI

Class II (US FDA UDI)

by Karl Storz GmbH & Co. KG

Identity

Trade Name
UNIDRIVE FDA UDI
Generic Name
Multi-purpose surgical power tool system, line-powered FDA UDI
Device Name
KARL STORZ UNIDRIVE® S III ENT with SCB FDA UDI
Model / Reference
40701620-1 FDA UDI
Description
KARL STORZ UNIDRIVE® S III ENT with SCB FDA UDI

Identifiers

Primary DI / UDI-DI
04048551253656 FDA UDI
FDA Product Code
ERL FDA UDI
GMDN Term
Multi-purpose surgical power tool system, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4250 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multi-purpose surgical power tool system, line-powered

Unidrive by Karl Storz GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose surgical power tool system, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Karl Storz GmbH & Co. KG

Sources (1)

  • FDA UDI 6b34d220-d4b3-43bd-b9d8-1551c47fa6cc 33 fields · synced May 30, 2026