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Erbe

FDA UDI

Class II (US FDA UDI)

by Erbe Elektromedizin GmbH

Identity

Trade Name
ERBE FDA UDI
Generic Name
Water jet knife system generator FDA UDI
Device Name
ERBEJET® 2 Hydrosurgical Unit FDA UDI
Model / Reference
10150-000 FDA UDI
Description
ERBEJET® 2 Hydrosurgical Unit FDA UDI

Identifiers

Catalog Number
10150-000 FDA UDI
Primary DI / UDI-DI
04050147000261 FDA UDI
510(k) Number
K072404 FDA UDI
K143306 FDA UDI
K231023 FDA UDI
FDA Product Code
FQH FDA UDI
GMDN Term
Water jet knife system generator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5475 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

Yes

FDA UDI

Category: Water jet knife system generator

Erbe by Erbe Elektromedizin GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Water jet knife system generator.

Cleared under the same submission

K072404 also covers:

K143306 also covers:

K231023 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Erbe Elektromedizin GmbH

Sources (1)

  • FDA UDI d7408454-0f0f-4f1c-9096-fe1fd4d31b7b 37 fields · synced May 30, 2026