Duns Number:092673953
Device Description: Demo User Kit with Travel Bag, VIBRALUNG®
Catalog Number
-
Brand Name
VIBRALUNG®
Version/Model Number
9501D
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
K133057
Product Code
BYI
Product Code Name
Percussor, Powered-Electric
Public Device Record Key
1998b865-074b-4035-9f70-eb17152ee6f9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 17, 2017
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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |