Duns Number:832696038
Device Description: V MUELLER VASCULAR LOOPS MINI WHITE STRL
Catalog Number
CH117
Brand Name
V. Mueller
Version/Model Number
CH117
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
-
Product Code
DXC
Product Code Name
CLAMP, VASCULAR
Public Device Record Key
f6115088-7f28-4f2f-afd6-f5b7a7c1d3b4
Public Version Date
May 06, 2020
Public Version Number
3
DI Record Publish Date
June 01, 2017
Package DI Number
50885403427785
Quantity per Package
8
Contains DI Package
20885403022590
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 | 8016 |
2 | A medical device with a moderate to high risk that requires special controls. | 6223 |