Duns Number:711091157
Device Description: Cryopreservation storage devices that are intended for use in vitrificationprocedures to c Cryopreservation storage devices that are intended for use in vitrificationprocedures to contain and maintain human oocytes (MII) and embryos.
Catalog Number
81185
Brand Name
CryotopUS-flash(Y)
Version/Model Number
CryotopUS-flash(Y)
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181469,K181469
Product Code
MQK
Product Code Name
LABWARE, ASSISTED REPRODUCTION
Public Device Record Key
bdf3e495-2ef9-43a6-bd11-260cd1823be0
Public Version Date
January 08, 2020
Public Version Number
2
DI Record Publish Date
June 01, 2019
Package DI Number
14582231462831
Quantity per Package
10
Contains DI Package
04582231462834
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |