Duns Number:007089246
Device Description: SporGon is a sterilant cleaning solution used in labs to clean surfaces, equipment and med SporGon is a sterilant cleaning solution used in labs to clean surfaces, equipment and medical devices.
Catalog Number
4301
Brand Name
SporGon
Version/Model Number
1 Gallon Bottle
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
K972708
Product Code
MED
Product Code Name
Sterilant, Medical Devices
Public Device Record Key
0fa4b3ff-112a-44d7-a8dc-4314cf202b91
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 02, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |