Duns Number:123853058
Device Description: Non-resorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 30 mm x 41 mm
Catalog Number
-
Brand Name
Cytoplast™ Titanium-Reinforced PTFE Membranes
Version/Model Number
Ti150PLT-N-1
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)
Yes
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
054dc476-518a-4a48-82b3-921de5fb2bec
Public Version Date
June 09, 2022
Public Version Number
1
DI Record Publish Date
June 01, 2022
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 226 |