AccessGUDID - DEVICE: Fertility Solutions (00860010518199)

GUDID

Device Identifier (DI) Information

Brand Name: Fertility Solutions
Version or Model: SA400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SA400
Company Name: Fertility Solutions, Inc.

Primary DI Number: 00860010518199
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 794781583 *Terms of Use

Device Description: 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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
GHO	Hemocytometer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Depth: 20 Micrometer

Device Record Status

Public Device Record Key: 2ccf14c8-cdbe-41f2-8c15-29483ddccc0f
Public Version Date: November 07, 2023
Public Version Number: 1
DI Record Publish Date: October 30, 2023