FDA UDI Not in Commercial Distribution 🇺🇸 United States

AMERICAN BIOSURGICAL

DI: 00852028007178 · Model: AB6002 · AMERICAN BIOSURGICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AMERICAN BIOSURGICAL
Primary DI
00852028007178
Version / Model
AB6002
Catalog Number
AB6002(S)
Company Name
AMERICAN BIOSURGICAL, LLC
Labeler DUNS
926239781
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-01-05
Public Version
5
Public Version Date
2022-04-14
Public Version Status
Update
Public Device Record Key
f8d2f13f-1469-4a22-b4c4-c62944e7c477
Distribution End Date
2022-04-13

Device Description

Disposable, 12 foot, Bipolar, Green Cable, Wolf to Wolf, Each

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
Yes
Sterilization Methods
Ethylene Oxide

Product Codes

Code Name
GEI Electrosurgical, Cutting & Coagulation & Accessories

GMDN Terms

Code Name
47143 Electrical-only medical device connection cable, single-use

Identifiers

Type ID
Primary 00852028007178