Duns Number:058614483
Device Description: Silicone Coated Braided Silk,HE-7,D/A,1x Black Strand
Catalog Number
-
Brand Name
Sofsilk
Version/Model Number
S-1766K
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
K981128,K981128
Product Code
GAP
Product Code Name
SUTURE, NONABSORBABLE, SILK
Public Device Record Key
d1e67cdd-e974-46fe-a10f-c2ecb552c06e
Public Version Date
May 03, 2022
Public Version Number
5
DI Record Publish Date
September 02, 2015
Package DI Number
20884521176376
Quantity per Package
12
Contains DI Package
10884521176379
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 |