Duns Number:092312735
Device Description: HARMON ANTI-NAUSEA WRIST BAND 12/144
Catalog Number
-
Brand Name
CORE VALUES
Version/Model Number
400851
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
MVV
Product Code Name
Device, Acupressure
Public Device Record Key
4577c737-0048-4ce1-9538-0acf57d83ffd
Public Version Date
September 08, 2020
Public Version Number
1
DI Record Publish Date
August 31, 2020
Package DI Number
10079573108519
Quantity per Package
12
Contains DI Package
00079573108512
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
inner
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 10 |