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Erbe

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 20132-046

by Erbe Elektromedizin GmbH

Identity

Trade Name
Anschlusskabel APC Applikator EUDAMED
ERBE FDA UDI
Generic Name
Inert gas-enhanced electrosurgical cable FDA UDI
Device Name
Cable for electrosurgical unit EUDAMED
Connect. cable for APC applic. APC 2; APC 300; L 2.5 m FDA UDI
Model / Reference
20132-046 EUDAMEDFDA UDI
Description
Connect. cable for APC applic. APC 2; APC 300; L 2.5 m FDA UDI

Identifiers

Catalog Number
20132-046 FDA UDI
Primary DI / UDI-DI
04050147000629 EUDAMEDFDA UDI
Basic UDI-DI
4050147Cable-HF-WX EUDAMED
Direct Marketing DI
04050147000629 EUDAMED
510(k) Number
K963189 FDA UDI
FDA Product Code
GEI FDA UDI
EMDN Code
K020180 SINGLE- AND BIPOLAR DEVICES, SINGLE USE - ACCESSORIES EUDAMED
GMDN Term
Inert gas-enhanced electrosurgical cable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 2.500 Meter FDA UDI

Category: Inert gas-enhanced electrosurgical cable

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

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Sources (2)

  • FDA UDI 8b54cbfb-6f14-4295-a575-daefd47eb330 38 fields · synced Jul 9, 2026
  • EUDAMED 2c8c91ee-5894-45bd-9661-f020ba4a93ad 61 fields · synced Jul 9, 2026