Duns Number:036514250
Device Description: Refurb SQL® SmartVest®, Wireless (Red)
Catalog Number
SQL_R-W-RD
Brand Name
SmartVest
Version/Model Number
SQL_R-W-RD
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132794
Product Code
BYI
Product Code Name
Percussor, Powered-Electric
Public Device Record Key
6f194234-23be-412a-ba4f-f992c3072231
Public Version Date
December 11, 2019
Public Version Number
4
DI Record Publish Date
July 18, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 158 |