Duns Number:481542926
Device Description: 14 C 53 8-0, Taper Lux 8-0, Nylon black, 15 cm, sterile Box with 12 sutures
Catalog Number
03395
Brand Name
NA
Version/Model Number
Surgical suture nonabsorbable monofil Taper Lux
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 10, 2020
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
GAR
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyamide
Public Device Record Key
7e7182e9-4aa0-493b-8627-c65640438425
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
ESOT033951
Quantity per Package
12
Contains DI Package
ESOT033950
Package Discontinue Date
March 10, 2020
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 306 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |