AccessGUDID - DEVICE: AMERICAN BIOSURGICAL (00852028007116)

GUDID

Device Identifier (DI) Information

Brand Name: AMERICAN BIOSURGICAL
Version or Model: AB 2001 B A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AB 2001 B A
Company Name: AMERICAN BIOSURGICAL, LLC

Primary DI Number: 00852028007116
Issuing Agency: GS1
Commercial Distribution End Date: April 13, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 926239781 *Terms of Use

Device Description: Reusable, 12 foot, Bipolar, Blue cable, Angled, Non-Sterile, Each

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2664c11c-42d1-45bb-b19b-0fc78878387f
Public Version Date: April 14, 2022
Public Version Number: 4
DI Record Publish Date: March 17, 2017