Duns Number:111585795
Device Description: 10-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 6 inch (15 cm) / Needl 10-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 6 inch (15 cm) / Needle Specifications: ST-160-6, Spatula Tip, 1/2 (160 degrees), length 5.60 mm, wire 0.15 mm / # of needles: Single Arm
Catalog Number
-
Brand Name
Sutralon
Version/Model Number
N106061
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
K994176,K994176,K994176
Product Code
GAR
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyamide
Public Device Record Key
da985acd-1fd4-4d3b-8479-d7b379da6649
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
May 09, 2016
Package DI Number
M583N1060613
Quantity per Package
12
Contains DI Package
M583N1060612
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 |