Duns Number:008965063
Device Description: 6 SPEED CORDLESS PERCUSSION MASSAGE GUN
Catalog Number
-
Brand Name
WALGREENS
Version/Model Number
350553
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ISA
Product Code Name
Massager, Therapeutic, Electric
Public Device Record Key
a3c28180-121d-4990-a6fa-3db450a76843
Public Version Date
March 19, 2021
Public Version Number
1
DI Record Publish Date
March 11, 2021
Package DI Number
10311917031573
Quantity per Package
12
Contains DI Package
00311917031576
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 75 |
2 | A medical device with a moderate to high risk that requires special controls. | 74 |
U | Unclassified | 2 |