Duns Number:116956807
Catalog Number
BRVE
Brand Name
BioMed Revived
Version/Model Number
Revived
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 13, 2019
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141299,K141299
Product Code
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
34cbe67e-b40e-44bf-9ed1-773413653652
Public Version Date
February 19, 2021
Public Version Number
11
DI Record Publish Date
November 11, 2016
Package DI Number
10857771003962
Quantity per Package
40
Contains DI Package
00857771003965
Package Discontinue Date
September 13, 2019
Package Status
Not in Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 80 |