DEVICE: Fertility Solutions (00860010518199)

Device Identifier (DI) Information

Fertility Solutions
SA400
In Commercial Distribution
SA400
Fertility Solutions, Inc.
00860010518199
GS1

25
794781583 *Terms of Use
Spermocytometer® sperm counting chambers. Box of 25 disposable slides each containing 2 single use counting chambers. 20 micron deep fixed coverslip glass chambers. Requires the use of an eyepiece reticle. https://www.fertilitysolutions.com/product-category/spermocytometer
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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?
43673 Microscope counting chamber IVD
A counting chamber intended to be used for the microscopic enumeration of cells, cellular particles, or other biological components present in clinical laboratory specimens.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GHO Hemocytometer
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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
Depth: 20 Micrometer
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Device Record Status

2ccf14c8-cdbe-41f2-8c15-29483ddccc0f
November 07, 2023
1
October 30, 2023
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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: 86001051819986 CLOSE

Direct Marking (DM)

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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
216-491-0030
businessmgr@fertilitysolutions.com
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