FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Fertility Solutions
DI: 08600105181998
·
Model: SA400
·
Fertility Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- Fertility Solutions
- Primary DI
- 08600105181998
- Version / Model
- SA400
- Catalog Number
- SA400
- Company Name
- Fertility Solutions, Inc.
- Labeler DUNS
- 794781583
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2023-09-15
- Public Version
- 2
- Public Version Date
- 2023-10-31
- Public Version Status
- Update
- Public Device Record Key
- 37bf9cee-9a1f-4516-82c0-00e4fe1e6c7c
- Distribution End Date
- 2023-10-29
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
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GHO | Hemocytometer | Hematology | 864.6160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 86001051819986 | GS1 | ||||
| Primary | 08600105181998 | GS1 |
Customer Contacts
- Phone
- 216-491-0030
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 20 | Micrometer |