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American Biosurgical

FDA UDI

Class II (US FDA UDI)

by Advantage Medical Electronics, LLC

Identity

Trade Name
American Biosurgical FDA UDI
Generic Name
Electrical-only medical device connection cable, single-use FDA UDI
Device Name
Disposable Bipolar Cord 12 ft FDA UDI
Model / Reference
22-7000-C FDA UDI
Description
Disposable Bipolar Cord 12 ft FDA UDI

Identifiers

Catalog Number
CB-AB 1000-1 (S) FDA UDI
Primary DI / UDI-DI
00849593019996 FDA UDI
510(k) Number
K953889 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Electrical-only medical device connection cable, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Electrical-only medical device connection cable, single-use

American Biosurgical by Advantage Medical Electronics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrical-only medical device connection cable, single-use.

Cleared under the same submission

K953889 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advantage Medical Electronics, LLC

Sources (1)

  • FDA UDI a16447f1-8030-45b7-8627-563c3e8ce1af 35 fields · synced Jun 1, 2026