Duns Number:341188943
Catalog Number
VMN-RS1
Brand Name
VELOCITY ALPHA ™
Version/Model Number
Reciprocating saw attachment
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K191479
Product Code
HBE
Product Code Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Public Device Record Key
e513de8b-54df-4ef7-a1ef-543c866105dd
Public Version Date
June 18, 2021
Public Version Number
1
DI Record Publish Date
June 10, 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 | 15 |
2 | A medical device with a moderate to high risk that requires special controls. | 535 |