Duns Number:305971764
Device Description: CRYOTUBE 1.0 ml SI Internal Starfoot Conical is used for storage and transportation of bio CRYOTUBE 1.0 ml SI Internal Starfoot Conical is used for storage and transportation of biological material for in vitro Diagnostics.
Catalog Number
-
Brand Name
CRYOTUBE 1.0 ml SI Internal Starfoot Conical
Version/Model Number
377224
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
0d80a618-4122-4470-baab-32105db026d2
Public Version Date
October 18, 2022
Public Version Number
1
DI Record Publish Date
October 10, 2022
Package DI Number
25713311000193
Quantity per Package
10
Contains DI Package
15713311000196
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 |