Duns Number:926239781
Device Description: Reusable, 10 foot, Monopolar, Grey Cable, Bovie Plug to 90 Degree Female Socket, Non-Steri Reusable, 10 foot, Monopolar, Grey Cable, Bovie Plug to 90 Degree Female Socket, Non-Sterile
Catalog Number
AB 5004 A
Brand Name
AMERICAN BIOSURGICAL
Version/Model Number
AB 5004 A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 13, 2022
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
56f07a82-a6a8-441b-bffa-2ad77ae07348
Public Version Date
April 14, 2022
Public Version Number
4
DI Record Publish Date
March 17, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |