Duns Number:009831413
Device Description: Sterile silk black braided 3/0 18 C31 nonabsorbable suture
Catalog Number
P00064
Brand Name
Quala silk suture
Version/Model Number
P00064
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
GAP
Product Code Name
Suture, Nonabsorbable, Silk
Public Device Record Key
a2cdf152-315c-46e9-9969-8dfee0157d77
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
February 13, 2017
Package DI Number
D023P0006419
Quantity per Package
12
Contains DI Package
D023P0006408
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 224 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 192 |