Duns Number:532176000
Device Description: box of 6 identical cartridges sealed in aluminum vacuum bag ;cartridge dimensions : 25mm d box of 6 identical cartridges sealed in aluminum vacuum bag ;cartridge dimensions : 25mm diameter ; 107mm long ;each cartridge filled with 31Gr of FlexiNylon Amhari/Purple Pink Thermoplastic pellets.
Catalog Number
222510
Brand Name
FlexiNylon cartridges Amhari/Purple Pink
Version/Model Number
25mm Diam. Extra Large 107mm long
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
-
Product Code
EBI
Product Code Name
Resin, Denture, Relining, Repairing, Rebasing
Public Device Record Key
1d8c1a36-a927-4b35-be1d-2b714a6b5e5f
Public Version Date
August 09, 2022
Public Version Number
1
DI Record Publish Date
August 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |