Duns Number:057475246
Device Description: Continuous Single Culture® Complete with HSA
Catalog Number
90165
Brand Name
Continuous Single Culture® Complete with Gentamicin Sulfate with Human Serum Alb
Version/Model Number
90165-2x20mL
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K121572,K121572
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
61d203e9-7f08-4504-8c95-d6e43ae86890
Public Version Date
February 13, 2019
Public Version Number
4
DI Record Publish Date
September 10, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 52 |