Duns Number:001307735
Device Description: Corning 2mL Internal Threaded Polypropylene Cryogenic Vial with Round Bottom
Catalog Number
430489
Brand Name
Corning®
Version/Model Number
430489
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
a0644b30-5f30-4ade-a6c3-ed174e719fcd
Public Version Date
March 23, 2022
Public Version Number
3
DI Record Publish Date
December 02, 2020
Package DI Number
H1084304893
Quantity per Package
10
Contains DI Package
H1084304891
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 |