Duns Number:218648211
Device Description: VOLITION 3.5MM CANNULATED SCREW CADDY
Catalog Number
OS720015-NS
Brand Name
Volition Plating System
Version/Model Number
OS720015-NS
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K163489
Product Code
OJH
Product Code Name
Orthopedic Tray
Public Device Record Key
544844e1-87cd-427e-926e-edb32db2c823
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
May 25, 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 | 262 |
2 | A medical device with a moderate to high risk that requires special controls. | 1530 |