Duns Number:001307735
Device Description: Corning Centrifuge Tube, 50mL Polypropylene Tube, self-standing centrifuge tube with with Corning Centrifuge Tube, 50mL Polypropylene Tube, self-standing centrifuge tube with with Tubing accessories and 0.2um Versapor filter, without Diptube, Sterile, 1 per bag, 2 per case
Catalog Number
11706
Brand Name
Corning
Version/Model Number
11706
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
f5c71e02-700b-42bd-9470-c19091c35f02
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
December 02, 2020
Package DI Number
H108117063
Quantity per Package
2
Contains DI Package
H108117061
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |