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DORO® Reusable Bipolar Cable

FDA UDI

Class II (US FDA UDI)

by pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Identity

Trade Name
DORO® Reusable Bipolar Cable FDA UDI
Generic Name
Electrical-only medical device connection cable, reusable FDA UDI
Device Name
DORO® Reusable Bipolar Cable, 4.6 m 2-Pin Plug (Erbe Plug) FDA UDI
Model / Reference
5011.222 FDA UDI
Description
DORO® Reusable Bipolar Cable, 4.6 m 2-Pin Plug (Erbe Plug) FDA UDI

Identifiers

Primary DI / UDI-DI
04250435513255 FDA UDI
510(k) Number
K070997 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Electrical-only medical device connection cable, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

DORO® Reusable Bipolar Cable by pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K070997 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Sources (1)

  • FDA UDI c50e900f-a55b-4c34-b3cc-97703299c649 35 fields · synced Jun 1, 2026