Duns Number:001307735
Device Description: Falcon® In Vitro Fertilization 4 Well Plate Tested for Embryotoxicity
Catalog Number
353654
Brand Name
Falcon
Version/Model Number
353654
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
K991249,K991249
Product Code
MQK
Product Code Name
Labware, Assisted Reproduction
Public Device Record Key
1a92b441-ebb2-48a6-9ced-d0bef7ab2912
Public Version Date
March 21, 2022
Public Version Number
6
DI Record Publish Date
September 22, 2016
Package DI Number
50389151000028
Quantity per Package
100
Contains DI Package
20389151000027
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |