DEVICE: CRYOLOCK(C) (B056CLRCTC1)
Device Identifier (DI) Information
CRYOLOCK(C)
CL-R-CT(C)
In Commercial Distribution
CL-R-CT (Clear)
BIOTECH INCORPORATED
CL-R-CT(C)
In Commercial Distribution
CL-R-CT (Clear)
BIOTECH INCORPORATED
Cryolock - Clear
Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47446 | Assisted reproduction vitrification carrier |
A sterile, plastic device used during an assisted reproduction vitrification (cryopreservation) procedure to hold a small volume of vitrification media containing a biological specimen (e.g., egg, embryo) to vitrify (cryopreserve) the specimen, thereby avoiding specimen immersion/contact with LN2. The vitrification process may involve the distal tip/specimen being brought into contact with the surface of a vitrification block [a highly-conductive mass of metal semi-submersed in a liquid nitrogen (LN2) bath]. The device with vitrified specimen is then stored in an LN2 tank, and subsequently transferred into a warming medium to recover the specimen. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MQK | Labware, Assisted Reproduction |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K122982 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b2288ac5-ad22-4998-8338-c40394764a9e
May 21, 2021
4
April 21, 2017
May 21, 2021
4
April 21, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B056CLRCTC5 | 36 | B056CLRCTC2 | In Commercial Distribution | Box | |
B056CLRCTC2 | 10 | B056CLRCTC1 | In Commercial Distribution | Pack of 50 | |
B056CLRCTC3 | 2 | B056CLRCTC1 | In Commercial Distribution | Pack of 10 | |
B056CLRCTC7 | 40 | B056CLRCTC2 | In Commercial Distribution | Box of 2000 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
B056CLRCTC0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-313-7793
BIOTECH@BIODISENO.COM
BIOTECH@BIODISENO.COM