Duns Number:058614483
Device Description: Silk Single Stitch Reload
Catalog Number
-
Brand Name
Sofsilk
Version/Model Number
170001
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
K934738,K934738
Product Code
OCW
Product Code Name
Endoscopic tissue approximation device
Public Device Record Key
f25fe20b-2d9b-48c0-b406-1deab1edab94
Public Version Date
May 02, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
10884521126848
Quantity per Package
12
Contains DI Package
20884521126845
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 |