Duns Number:080214481
Device Description: Disinfectant soak for instruments.
Catalog Number
-
Brand Name
Micro-Scientific Opti-Cide3 Instrument Soak with Rust Inhibitor
Version/Model Number
NE209
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
98b5f669-b39c-4cbb-8c27-9778fb0b98c4
Public Version Date
September 02, 2022
Public Version Number
1
DI Record Publish Date
August 25, 2022
Package DI Number
10739470100091
Quantity per Package
12
Contains DI Package
00739470100094
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 13 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |