Duns Number:001307735
Device Description: Corning Cryogenic vial, 5mL, clear, round bottom, self-standing, external threaded, polypr Corning Cryogenic vial, 5mL, clear, round bottom, self-standing, external threaded, polypropylene, non printed, cap unassembled, sterile, bulk
Catalog Number
430674
Brand Name
Corning®
Version/Model Number
430674
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
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
86812a94-d44e-48e2-9a99-6d004786d6db
Public Version Date
March 23, 2022
Public Version Number
3
DI Record Publish Date
December 02, 2020
Package DI Number
H1084306743
Quantity per Package
4
Contains DI Package
H1084306741
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 387 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |