Duns Number:071595540
Device Description: 5MM X 43CM ENDOWEAVE TIP MONOPOLAR GRASPER
Catalog Number
60-6045-435
Brand Name
NA
Version/Model Number
60-6045-435
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 09, 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"
-
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
K943327,K943327,K943327
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
0bea3d9d-2a89-48df-b5a8-3064a590b39f
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
20653405038822
Quantity per Package
5
Contains DI Package
30653405038829
Package Discontinue Date
June 09, 2022
Package Status
Not 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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |