Duns Number:058614483
Device Description: Wax Coated Braided Silk
Catalog Number
-
Brand Name
Sofsilk
Version/Model Number
VS671-2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 12, 2021
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
K981128,K981128
Product Code
GAP
Product Code Name
SUTURE, NONABSORBABLE, SILK
Public Device Record Key
3d170cd2-b701-42e2-a111-ae6a3f009328
Public Version Date
May 03, 2022
Public Version Number
4
DI Record Publish Date
July 19, 2020
Package DI Number
20884521758022
Quantity per Package
36
Contains DI Package
10884521758025
Package Discontinue Date
February 12, 2021
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 |