Duns Number:618960848
Device Description: BIO Max Screw Impression Open Tray RP
Catalog Number
-
Brand Name
Blue Sky Bio, LLC
Version/Model Number
SMLJHR
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EHY
Product Code Name
Tray, Impression, Preformed
Public Device Record Key
2ed2f83f-239a-4310-97ae-01a35605984c
Public Version Date
October 12, 2022
Public Version Number
2
DI Record Publish Date
July 21, 2021
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 | 591 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 912 |