Duns Number:001307735
Device Description: Corning Cap for Internal Threated Cryogenic Vial,Sterile, Bulk
Catalog Number
431349
Brand Name
Corning®
Version/Model Number
431349
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
58464a36-c856-4c82-ba4c-969aabdd2e00
Public Version Date
March 23, 2022
Public Version Number
3
DI Record Publish Date
December 02, 2020
Package DI Number
H1084313493
Quantity per Package
10
Contains DI Package
H1084313491
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 |