Duns Number:121464288
Device Description: Supplied as a pair for use in jaws of resuable clamps.
Catalog Number
N-10146v
Brand Name
InTrack® Inserts
Version/Model Number
N-10146v
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
K992980,K992980
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
97e7adec-3d71-44de-a047-5b4930a01690
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 26, 2016
Package DI Number
10852621004120
Quantity per Package
20
Contains DI Package
00852621004123
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |