Duns Number:832696038
Device Description: V MUELLER VASCULAR LOOP-MINI-YELLOW STR.
Catalog Number
CH116
Brand Name
V. Mueller
Version/Model Number
CH116
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
c8ed3b4b-7bac-40b5-85f2-621586211232
Public Version Date
May 06, 2020
Public Version Number
3
DI Record Publish Date
June 01, 2017
Package DI Number
50885403427778
Quantity per Package
8
Contains DI Package
20885403022583
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 |