DEVICE: Cryotec (04589700010190)

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Device Record History
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Device Identifier (DI) Information
Cryotec
TEC104G
Not in Commercial Distribution
TEC104G
REPROLIFE INC.
04589700010190
GS1
August 31, 2017
4
691176883 *Terms of Use
Kitazato Cryotec (4 pieces) (Green)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
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?
48007 Tissue cryostorage straw
A long, thin, tubular sterile device in the form of a straw used for the placement and storage of human biological samples such as embryos, oocytes, sperm, and human tissue in liquid nitrogen (LN2) or in the volumes of vapour phase LN2 in a liquid nitrogen container. It is made of materials to withstand storage in LN2 and is available in a variety of designs that may include a sliding plug or a permeable membrane plug to hold the sample. The sample is inserted into one end of the device and both ends are sealed, typically by using a thermal sealing device, creating an airtight seal to protect the sample from direct contact with the LN2. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MQK Labware, Assisted Reproduction
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K162051 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 20 Degrees Celsius
Handling Environment Temperature: between 10 and 20 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
99bdc1fd-295e-4f84-98b5-08c742aeb750
October 18, 2023
5
August 31, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 45897000119015 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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