DEVICE: Vitalscreen (00805360018470)

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Device Record History
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Device Identifier (DI) Information
Vitalscreen
15643
In Commercial Distribution

VITROLIFE INC.
00805360018470
GS1

1
051915038 *Terms of Use
Vitalscreen
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
57761 10% Neutral buffered formalin/0.03% eosin IVD
A 10% neutral buffered formalin solution with 0.03% eosin solution intended to be used as a fixative in the processing of biological tissues or clinical specimens.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
POV Semen Analysis Device
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
4a4bfd58-5431-4e27-aa1c-ae9a4349127c
April 29, 2020
2
April 23, 2018
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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