Duns Number:063554875
Device Description: MONOFILAMENT 316 LVMSTAINLESS STEEL SUTURE,BE2 NEEDLE, 65MM, USP 6, 14", 2 PK
Catalog Number
-
Brand Name
TITAN™ DOUBLE WIRE
Version/Model Number
132.640.62
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
PTX
Product Code Name
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt
Public Device Record Key
24a40cc6-db16-4e0d-b9d7-c543acafc45c
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
October 10, 2021
Package DI Number
00853190008147
Quantity per Package
12
Contains DI Package
00853190008949
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 125 |