Duns Number:711091157
Catalog Number
-
Brand Name
Hypure Oil Heavy 100mL
Version/Model Number
MOHV-100
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"
Yes
For Single-Use
Yes
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
MQL
Product Code Name
MEDIA, REPRODUCTIVE
Public Device Record Key
a9c869b2-662f-4d65-a538-50362c797230
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 08, 2016
Package DI Number
14582231460349
Quantity per Package
1
Contains DI Package
04582231460342
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. | 177 |