Duns Number:123853058
Device Description: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites.
Catalog Number
-
Brand Name
RPM™ Reinforced PTFE Mesh
Version/Model Number
RPM250XL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2022
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
K171774
Product Code
NPK
Product Code Name
Barrier, Synthetic, Intraoral
Public Device Record Key
c1e4e425-8ab7-426a-b112-f39125dc1373
Public Version Date
October 06, 2022
Public Version Number
2
DI Record Publish Date
March 04, 2019
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 |