Duns Number:187129135
Device Description: Disposable Grasper Cartridge
Catalog Number
-
Brand Name
Direct Drive Reposable Graspers
Version/Model Number
C4121
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"
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
NWV
Product Code Name
Laparoscopic Accessories, Gynecologic
Public Device Record Key
b1edf794-4924-44dc-901a-9819914cf9a9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 30, 2016
Package DI Number
10607915116870
Quantity per Package
10
Contains DI Package
00607915116873
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 499 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 698 |
| 3 | A medical device with high risk that requires premarket approval | 1 |