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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, reusable FDA UDI
Device Name
Disposable, 10 Foot, Monopolar, Green cable, 90 Degree Socket, Sterile, Box 10 FDA UDI
Model / Reference
AB 5003-0 (S) FDA UDI
Description
Disposable, 10 Foot, Monopolar, Green cable, 90 Degree Socket, Sterile, Box 10 FDA UDI

Identifiers

Catalog Number
CB-AB 5003-0 (S) FDA UDI
Primary DI / UDI-DI
00849593024990 FDA UDI
510(k) Number
K971540 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

Cleared under the same submission

K971540 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 8c674793-763c-4bf0-8af9-deb5c400ce03 36 fields · synced Jun 8, 2026