Duns Number:532176000
Device Description: Biosens Disc Clear for milling made from Thermoplastic resin 98.4mm Diameter 16mm thicknes Biosens Disc Clear for milling made from Thermoplastic resin 98.4mm Diameter 16mm thickness
Catalog Number
4119816
Brand Name
Biosens Disc
Version/Model Number
Clear 16mm
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
98238b2f-59b9-4379-b0a4-e13b1b268db9
Public Version Date
June 23, 2020
Public Version Number
1
DI Record Publish Date
June 15, 2020
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 |