Duns Number:039436691
Device Description: Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
Catalog Number
-
Brand Name
Demetech PTFE
Version/Model Number
TE1056013C0P
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
K181578,K181578
Product Code
NBY
Product Code Name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Public Device Record Key
54ac05fb-cade-44c6-a12a-a1c0bae33885
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
July 10, 2019
Package DI Number
30652927671873
Quantity per Package
12
Contains DI Package
10652927671879
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 13232 |