Duns Number:080242300
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
-
Brand Name
American Biosurgical
Version/Model Number
CB-AB 5004
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
-
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
K971540,K971540,K971540
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
b153f1f3-adb4-4b22-892f-437d3fd51a11
Public Version Date
June 09, 2021
Public Version Number
1
DI Record Publish Date
June 01, 2021
Package DI Number
10849593019870
Quantity per Package
10
Contains DI Package
00849593019873
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1261 |