Duns Number:111585795
Device Description: 6-0 Suture USP / Thread Specifications: Silk, Black Braided, 30 inch (76 cm) / Needle Spec 6-0 Suture USP / Thread Specifications: Silk, Black Braided, 30 inch (76 cm) / Needle Specifications: ST-140-11, Spatula Tip, 3/8 circle (140 degrees), length 8.0 mm, wire 0.28mm / # of needles: Double arm
Catalog Number
-
Brand Name
Sutrasilk
Version/Model Number
S640112
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
K994177,K994177,K994177
Product Code
GAP
Product Code Name
Suture, Nonabsorbable, Silk
Public Device Record Key
f712a087-5fce-45c3-a422-fe1d4c772e67
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
September 06, 2016
Package DI Number
M583S6401123
Quantity per Package
12
Contains DI Package
M583S6401122
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |