Duns Number:121464288
Device Description: Reusable, Surgical Vascular Clamp for vessel occlusion
Catalog Number
-
Brand Name
InTrack Clamp
Version/Model Number
N-10111v
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
-
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
K992640
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
022d47db-14ed-4c8b-9e5f-cd54914eef7b
Public Version Date
January 14, 2019
Public Version Number
1
DI Record Publish Date
December 13, 2018
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 | 163 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 72 |