Duns Number:006309355
Device Description: OPTI-CIDE 2 x 2.5 GAL Solution - RTU Disinfectant (BIOTROL)
Catalog Number
DOCP02-320
Brand Name
Biotrol
Version/Model Number
DOCP02-320
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
Yes
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
LRJ
Product Code Name
Disinfectant, medical devices
Public Device Record Key
6faa03cf-b527-48c4-b33d-787922e1f75c
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 16, 2022
Package DI Number
10302730000068
Quantity per Package
2
Contains DI Package
00302730000061
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Jug - Bottle
| 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 |