Duns Number:197386191
Catalog Number
-
Brand Name
reVive Light Therapy®
Version/Model Number
RVPOOFW
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
9b260833-5784-49ae-8bf5-adce1ca7a576
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
January 23, 2018
Package DI Number
B347RVPOOFW1
Quantity per Package
24
Contains DI Package
B347RVPOOFW0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 49 |