Duns Number:001307735
Device Description: Falcon 19mL Round Bottom Polystyrene Test Tube, with Screw Cap, Sterile, Individually Wra Falcon 19mL Round Bottom Polystyrene Test Tube, with Screw Cap, Sterile, Individually Wrapped, 500/Case
Catalog Number
352045
Brand Name
Falcon A Corning Brand
Version/Model Number
352045
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
ee2fdd5c-1c49-401e-bf17-8cfa0eaf0db9
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
December 02, 2020
Package DI Number
H1083520453
Quantity per Package
1
Contains DI Package
H1083520451
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 |