Duns Number:001307735
Device Description: Falcon 525cm² Rectangular Straight Neck Cell Culture Multi-Flask, 3-layer with Vented Cap Falcon 525cm² Rectangular Straight Neck Cell Culture Multi-Flask, 3-layer with Vented Cap2/Pack, 12/case
Catalog Number
353143
Brand Name
Falcon
Version/Model Number
353143
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
KJA
Product Code Name
Flask, tissue culture
Public Device Record Key
28ab3814-7ae3-42d7-aa44-34dffafb121c
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
December 29, 2020
Package DI Number
50389151000592
Quantity per Package
6
Contains DI Package
10389151000594
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 |