Duns Number:111585795
Device Description: 9-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 12 inch (30 cm) 9-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 12 inch (30 cm) / Needle Specifications: ST-000-6, Spatula Tip, straight (0 degrees), length 16 mm, wire 0.15 mm AND Needle Specifications: ST-90-6, Spatula Tip, 1/4 circle (90 degrees), length 16 mm, wire 0.15 mm / # of needles: Double arm
Catalog Number
-
Brand Name
Sutralene
Version/Model Number
P9009062
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
K070243,K070243,K070243
Product Code
GAW
Product Code Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Public Device Record Key
1b1f7136-15ef-47a1-9ccc-3ce40642c308
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
June 14, 2016
Package DI Number
M583P90090623
Quantity per Package
12
Contains DI Package
M583P90090622
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 |