Duns Number:111585795
Device Description: 10-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 16 inch (40 cm) / Need 10-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 16 inch (40 cm) / Needle Specifications: ST-140-8, Spatula Tip, 3/8 (140 degrees), length 6.00 mm, wire 0.20 mm / # of needles: Double Arm
Catalog Number
-
Brand Name
Sutralon
Version/Model Number
N104082
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
ad11cdbb-bf42-4e02-b7f8-ccede9c9b33c
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
May 13, 2016
Package DI Number
M583N1040823
Quantity per Package
12
Contains DI Package
M583N1040822
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 |