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Erbe

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 20150-236

by Erbe Elektromedizin GmbH

Identity

Trade Name
Applikator;gerade; monopolar EUDAMED
ERBE FDA UDI
Generic Name
Water jet knife system handpiece, single-use FDA UDI
Device Name
Monopolar applicators, SU EUDAMED
Applicator w/coagulation and suction; OD 6mm; L 80mm FDA UDI
Model / Reference
20150-236 EUDAMEDFDA UDI
Description
Applicator w/coagulation and suction; OD 6mm; L 80mm FDA UDI

Identifiers

Catalog Number
20150-236 FDA UDI
Primary DI / UDI-DI
04050147024106 EUDAMEDFDA UDI
Basic UDI-DI
B-04050147024106 EUDAMED
510(k) Number
K072404 FDA UDI
K083608 FDA UDI
FDA Product Code
FQH FDA UDI
EMDN Code
K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
GMDN Term
Water jet knife system handpiece, single-use FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
880.5475 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 6.000 Millimeter FDA UDI
Length — 80.000 Millimeter FDA UDI

Category: Water jet knife system handpiece, single-use

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

Similar devices

Also classified as Water jet knife system handpiece, single-use.

Cleared under the same submission

K072404 also covers:

K083608 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Erbe Elektromedizin GmbH

Sources (2)

  • FDA UDI f4b66178-2a32-475f-9936-b87f0ce87d73 38 fields · synced Jun 18, 2026
  • EUDAMED ba25bde5-d582-4dd2-9390-9e7445f373d5 61 fields · synced Jun 18, 2026