Duns Number:080844844
Device Description: CRYOGENIC VIAL,BAR CODED
Catalog Number
-
Brand Name
Nalgene™ Cryogenic Tube, 2 mL externally-threaded, Barcoded
Version/Model Number
5001-0020
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
02a18ec1-926d-41e7-8686-a71b2551f26e
Public Version Date
August 03, 2022
Public Version Number
1
DI Record Publish Date
July 26, 2022
Package DI Number
30850016058646
Quantity per Package
500
Contains DI Package
10850016058642
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |