Duns Number:008496861
Device Description: Convenience kit containing Total Fix, Formalin, C&S and Clean Vials for stool sample colle Convenience kit containing Total Fix, Formalin, C&S and Clean Vials for stool sample collection.
Catalog Number
892-02
Brand Name
Total-Fix / Formalin / C&S / Clean O&P Collection Kits
Version/Model Number
892-02
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IFP
Product Code Name
Formalin, Neutral Buffered
Public Device Record Key
e227617b-eb55-42d2-9381-8e9f60be1f07
Public Version Date
September 08, 2020
Public Version Number
1
DI Record Publish Date
August 31, 2020
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 | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |