Duns Number:631805488
Catalog Number
-
Brand Name
THAW-KIT 1
Version/Model Number
10067
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 25, 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
K000618
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
cd90a027-976d-4b03-ac9c-b499f51b7c0c
Public Version Date
September 28, 2020
Public Version Number
4
DI Record Publish Date
September 13, 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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 157 |