Duns Number:058614483
Device Description: Coated Braided Polyester
Catalog Number
VCD-54
Brand Name
Ti-Cron
Version/Model Number
VCD-54
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 02, 2015
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
K930591,K930591
Product Code
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
644c41d2-3d9f-449a-a20b-a9ebfdd6a5a3
Public Version Date
February 01, 2022
Public Version Number
6
DI Record Publish Date
September 02, 2015
Package DI Number
20884521170329
Quantity per Package
6
Contains DI Package
10884521170322
Package Discontinue Date
September 02, 2015
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 |