Duns Number:006309355
Device Description: Glutaraldehyde cold sterilant
Catalog Number
-
Brand Name
Biocide G30
Version/Model Number
BIOG30CS
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
K914749,K914749
Product Code
MED
Product Code Name
Sterilant, Medical Devices
Public Device Record Key
d490f482-7235-4414-9ded-583800e93240
Public Version Date
October 05, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
20302730000027
Quantity per Package
4
Contains DI Package
10302730000020
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipping box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 138 |
2 | A medical device with a moderate to high risk that requires special controls. | 85 |