Duns Number:017524666
Device Description: PTFE Sutures, Non-absorbable, 5-0, monofilament, 13mm 3/8 circle Rev Cut, 18"
Catalog Number
S-F518R13
Brand Name
UNIFY PTFE Surgical Sutures
Version/Model Number
S-F518R13
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K170842,K170842,K170842
Product Code
NBY
Product Code Name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Public Device Record Key
9b01a942-4bc4-4bda-8463-fc31af088598
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 30, 2017
Package DI Number
20814639023682
Quantity per Package
100
Contains DI Package
10814639023685
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 121 |