Duns Number:057475246
Device Description: Tyrode's Solution - Acidified
Catalog Number
99252
Brand Name
Tyrode's Solution - Acidified
Version/Model Number
99252-12X5ML
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 06, 2020
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K991339,K991339
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
3e540c11-6332-4d45-8379-a0bfdf63186d
Public Version Date
August 06, 2020
Public Version Number
6
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 |