DEVICE: CryoTip® (00893727002118)

Device Identifier (DI) Information

CryoTip®
40709-Pack
In Commercial Distribution
40709
FUJIFILM IRVINE SCIENTIFIC, INC.
00893727002118
GS1

5
057475246 *Terms of Use
CryoTip
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Assisted reproduction cryotube A sterile container (a dedicated sealable tube) intended for transport, storage and preparation of biological samples of human origin used in assisted reproduction techniques (ART), e.g., embryos. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in, in vitro fertilization (IVF) and ART clinics. Its main application being to hold biological materials when stored in a frozen state at temperatures below -130 Celsius (e.g., stored in the gas phase above the liquid nitrogen (LN2) at temperatures around -178 C to -150 C). This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
MQH Microtools, Assisted Reproduction (Pipettes)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K041562 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 15 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

8d687168-1a9d-41ca-b440-af402a56e51e
February 13, 2019
4
September 10, 2016
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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: 10893727002115 CLOSE

Direct Marking (DM)

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

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
8004375706
tmrequest@irvinesci.com
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