Duns Number:111585795
Device Description: 6-0 Suture USP / Thread Specifications: PGA, 12 inch (30 cm) / Needle Specifications: ST-9 6-0 Suture USP / Thread Specifications: PGA, 12 inch (30 cm) / Needle Specifications: ST-90-8, Spatula Tip, 1/4 (90 degrees), length 7.6 mm, wire 0.20 mm / # of needles: Double arm
Catalog Number
-
Brand Name
Sutrazorb
Version/Model Number
A69082-1
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
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
859f772b-64b2-4bf7-9c3f-eb40f4232e8f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 13, 2016
Package DI Number
M583A6908213
Quantity per Package
12
Contains DI Package
M583A6908212
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 |