Duns Number:829465157
Device Description: Black Braided Siliconized Silk, Nonabsorbable Surgical Suture
Catalog Number
10Q06
Brand Name
PERMA-HAND
Version/Model Number
10Q06
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 17, 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
K946173,K946173
Product Code
GAP
Product Code Name
SUTURE, NONABSORBABLE, SILK
Public Device Record Key
2a6c26d9-8167-479b-bd05-4cae7397376e
Public Version Date
November 17, 2021
Public Version Number
5
DI Record Publish Date
September 01, 2015
Package DI Number
30705031001248
Quantity per Package
12
Contains DI Package
10705031001244
Package Discontinue Date
November 17, 2021
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1028 |
| 3 | A medical device with high risk that requires premarket approval | 15 |
| U | Unclassified | 1 |