Duns Number:040729840
Device Description: Micasept Babcock Clamp/Node Grasper With Round Ratchet Atraumatic 30 Degrees Curved Down 4 Micasept Babcock Clamp/Node Grasper With Round Ratchet Atraumatic 30 Degrees Curved Down 4.5 Millimeters
Catalog Number
-
Brand Name
Micaspet Babcock Clamp/Node Grasper
Version/Model Number
20919-12
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
-
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
K002877
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
e5020f7e-865c-482f-b01c-3d20d3a9dd1d
Public Version Date
May 13, 2021
Public Version Number
1
DI Record Publish Date
May 05, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |