Duns Number:080129843
Device Description: Cryolock - YellowCryopreservation storage device that is intended for use in vitrification Cryolock - YellowCryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
Catalog Number
CL-R-CT (Yellow)
Brand Name
CRYOLOCK(Y)
Version/Model Number
CL-R-CT(Y)
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122982,K122982,K122982,K122982,K122982,K122982
Product Code
MQK
Product Code Name
Labware, Assisted Reproduction
Public Device Record Key
e954214a-cb29-4a98-825d-0cdd23ebfe42
Public Version Date
May 21, 2021
Public Version Number
4
DI Record Publish Date
April 20, 2017
Package DI Number
B056CLRCTY5
Quantity per Package
36
Contains DI Package
B056CLRCTY2
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box