Duns Number:018577570
Catalog Number
733M1675
Brand Name
Vitality®+ Osteotomy
Version/Model Number
733M1675
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
-
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
HTF
Product Code Name
CURETTE
Public Device Record Key
f58a2b8d-fdc9-4fd0-b0b1-1378882cfd7b
Public Version Date
March 10, 2022
Public Version Number
3
DI Record Publish Date
June 05, 2018
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 | 491 |
2 | A medical device with a moderate to high risk that requires special controls. | 31582 |
U | Unclassified | 546 |