Duns Number:447696675
Device Description: PTFE Suture 60 cm - 5/0 - 12 mm Needle 1/2 - Body Reverse Cutting
Catalog Number
-
Brand Name
Sterile PTFE Surgical Suture
Version/Model Number
32.Z4402.00
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
NBY
Product Code Name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Public Device Record Key
5f6346ca-d73f-441f-8a74-b6d3e7ef2b33
Public Version Date
December 21, 2018
Public Version Number
3
DI Record Publish Date
February 27, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |