Duns Number:058614483
Device Description: Absorbable Wound Closure Device
Catalog Number
-
Brand Name
VLOC 180
Version/Model Number
VLOCL5123
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
K091087,K091087
Product Code
GAM
Product Code Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Public Device Record Key
1d435cb4-96f6-461a-ac81-001220558de9
Public Version Date
February 07, 2022
Public Version Number
5
DI Record Publish Date
May 03, 2018
Package DI Number
20884521749853
Quantity per Package
12
Contains DI Package
10884521749856
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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |