Duns Number:276593071
Device Description: VASCULAR CLAMP MCEN190 STRGT ROT WORMALD
Catalog Number
MCEN190
Brand Name
Integra® MicroFrance®
Version/Model Number
MCEN190
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
K112662
Product Code
DXC
Product Code Name
CLAMP, VASCULAR
Public Device Record Key
6e7b5682-f5ba-4e76-ba34-19acda15951c
Public Version Date
October 04, 2022
Public Version Number
7
DI Record Publish Date
September 20, 2016
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 | 1433 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 879 |