Duns Number:612250175
Catalog Number
BP4510
Brand Name
Disposable PowerGrip Bipolar Instrument Cord
Version/Model Number
BP4510
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 21, 2018
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
Yes
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
929fa583-5871-4522-a499-23296fcb7621
Public Version Date
October 19, 2020
Public Version Number
6
DI Record Publish Date
August 31, 2016
Package DI Number
30815288013373
Quantity per Package
50
Contains DI Package
10815288013379
Package Discontinue Date
May 21, 2018
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 208 |