Duns Number:002348191
Device Description: Nylon Black Monofilament Size 3-0 24" T-2 Needle
Catalog Number
0100019-540
Brand Name
DEKNATEL
Version/Model Number
IPN000846
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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"
Yes
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
GAR
Product Code Name
Suture, nonabsorbable, synthetic, polyamide
Public Device Record Key
5950f1af-096d-4beb-8df2-84ea2b201465
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
January 15, 2019
Package DI Number
34026704602415
Quantity per Package
36
Contains DI Package
14026704602411
Package Discontinue Date
October 01, 2020
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |