Duns Number:080935429
Device Description: Vessel Loops,Maxi, Blue
Catalog Number
31145678
Brand Name
Devon
Version/Model Number
31145678
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
68ce9916-76cd-4213-99d2-103b8f00ee04
Public Version Date
September 10, 2019
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
10884521152076
Quantity per Package
200
Contains DI Package
20884521152073
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 | 672 |
2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
U | Unclassified | 17 |