Duns Number:123853058
Device Description: Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 20 mm x 25 mm
Catalog Number
-
Brand Name
Cytoplast™ Titanium-Reinforced PTFE Membranes
Version/Model Number
Ti150PS-N-2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
NPK
Product Code Name
Barrier, Synthetic, Intraoral
Public Device Record Key
d28fe651-f156-4ce7-9eb5-b3fd647821c7
Public Version Date
June 09, 2022
Public Version Number
1
DI Record Publish Date
June 01, 2022
Package DI Number
D765TI150PSN21
Quantity per Package
2
Contains DI Package
D765TI150PSN20
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. | 226 |