Duns Number:001307735
Device Description: Falcon® 60 x 15 mm IVF One Well Dish Tested for Embryotoxicity
Catalog Number
353653
Brand Name
Falcon
Version/Model Number
353653
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
K991251,K991251,K991251
Product Code
MQK
Product Code Name
Labware, Assisted Reproduction
Public Device Record Key
8cf2af5a-b2c7-4f94-99e0-5b9b561c4385
Public Version Date
March 21, 2022
Public Version Number
6
DI Record Publish Date
September 22, 2016
Package DI Number
50389151000011
Quantity per Package
25
Contains DI Package
20389151000010
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 |