Duns Number:197386191
Catalog Number
-
Brand Name
Hammacher Schlemmer
Version/Model Number
HSAAMITT
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
OHS
Product Code Name
Light Based Over The Counter Wrinkle Reduction
Public Device Record Key
a62c35f6-8021-4531-a550-70a75dcc8a7a
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
April 17, 2018
Package DI Number
B347HSAAMITT1
Quantity per Package
20
Contains DI Package
B347HSAAMITT0
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 |