Identity
- Trade Name
- Fertility Solutions FDA UDI
- Generic Name
- Sperm concentration indicator IVD, control FDA UDI
- Device Name
- Post Vasectomy Quality Control containing stabilized human sperm, 2 vials of 300 µL each, 2 levels - positive and negative. https://www.fertilitysolutions.com/product-category/post-vasectomy-quality-control FDA UDI
- Model / Reference
- FSI111 FDA UDI
- Description
- Post Vasectomy Quality Control containing stabilized human sperm, 2 vials of 300 µL each, 2 levels - positive and negative. https://www.fertilitysolutions.com/product-category/post-vasectomy-quality-control FDA UDI
Identifiers
- Catalog Number
- FSI111 FDA UDI
- Primary DI / UDI-DI
- 08600105181202 FDA UDI
- FDA Product Code
- NRF FDA UDI
- GMDN Term
- Sperm concentration indicator IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Fertility Solutions by Fertility Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fertility Solutions, Inc.
Sources (1)
- FDA UDI f4a4580d-5eff-4f74-a14f-d9ef10b1a417 38 fields · synced May 30, 2026