Duns Number:002348191
Device Description: Babcock Grasper
Catalog Number
BCK250
Brand Name
MINILAP
Version/Model Number
IPN002697
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
K070686,K070686,K070686
Product Code
OCW
Product Code Name
Endoscopic tissue approximation device
Public Device Record Key
98296d1b-4cb0-4c61-a941-36ef330ac099
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
24026704582581
Quantity per Package
6
Contains DI Package
14026704582584
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Blister Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |