Duns Number:002348191
Device Description: V-PAK ASST'D SUTURES
Catalog Number
V-3807
Brand Name
DEKNATEL
Version/Model Number
IPN026643
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
Product Code
OVN
Product Code Name
Suture kit
Public Device Record Key
f9eb8220-989d-42b5-b3fb-f166a59545bb
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 16, 2015
Package DI Number
24026704555349
Quantity per Package
12
Contains DI Package
04026704555345
Package Discontinue Date
March 09, 2018
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |