Duns Number:080129843
Device Description: S-CRYOLOCK - CLEAR - Cryopreservation storage device that is intended for use in vitrifica S-CRYOLOCK - CLEAR - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
Catalog Number
S-CL (CLEAR)
Brand Name
S-CRYOLOCK (C)
Version/Model Number
S-CL (C)
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
Product Code
MQK
Product Code Name
Labware, Assisted Reproduction
Public Device Record Key
265ef6a5-4f07-48cb-8a09-5b7d5879185c
Public Version Date
May 21, 2021
Public Version Number
2
DI Record Publish Date
April 26, 2019
Package DI Number
B056SCLC5
Quantity per Package
40
Contains DI Package
B056SCLC2
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX/2000