Duns Number:305088619
Device Description: Bipolar Cutting & Coagulation forceps, 5mm, 3m cable, 4mm pins, straight, length 160mm
Catalog Number
5005-160
Brand Name
LiNA PowerBlade™
Version/Model Number
5005-160
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
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
d163a236-906d-4b9d-9a9f-c57b7d85817e
Public Version Date
April 23, 2019
Public Version Number
3
DI Record Publish Date
September 15, 2016
Package DI Number
05708265001026
Quantity per Package
5
Contains DI Package
05708265001019
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |