Duns Number:929504710
Device Description: PermaFluor™ Aqueous Mounting Medium
Catalog Number
-
Brand Name
Thermo Scientific
Version/Model Number
TA-030-FM
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LED
Product Code Name
Stains, Chemical Solution
Public Device Record Key
82fdcf5e-82e6-479d-9dd4-4ae51899f3b1
Public Version Date
July 02, 2018
Public Version Number
1
DI Record Publish Date
June 01, 2018
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 906 |
2 | A medical device with a moderate to high risk that requires special controls. | 10 |