Duns Number:305971764
Device Description: CryoTube 3,6 ml SI Internal thread round is used for storage and transportation of biologi CryoTube 3,6 ml SI Internal thread round is used for storage and transportation of biological material for in vitro Diagnostics.
Catalog Number
-
Brand Name
CryoTube 3,6 ml SI Internal thread round
Version/Model Number
366524
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMH
Product Code Name
Container, Specimen, Sterile
Public Device Record Key
97cae84a-7e42-4dca-9558-9a6f88da7d68
Public Version Date
October 18, 2022
Public Version Number
1
DI Record Publish Date
October 10, 2022
Package DI Number
25713311000186
Quantity per Package
8
Contains DI Package
15713311000189
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |