Duns Number:058614483
Device Description: PBT Non Absorbable Wound Closure Device
Catalog Number
-
Brand Name
V-Loc
Version/Model Number
VLOCN1125
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 02, 2019
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
K103052,K103052
Product Code
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
24556c6d-278d-4744-8a1a-25d059d393d4
Public Version Date
January 28, 2022
Public Version Number
7
DI Record Publish Date
September 02, 2015
Package DI Number
10884521127913
Quantity per Package
12
Contains DI Package
20884521127910
Package Discontinue Date
October 02, 2019
Package Status
Not 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 |