Identity
- Trade Name
- SpermSelect Mini Kit FDA UDI
- Generic Name
- Spermatozoa/semen motility medium supplement FDA UDI
- Device Name
- Contents: one SpermSelect System and one MiniSpace FDA UDI
- Model / Reference
- SM601-F FDA UDI
- Description
- Contents: one SpermSelect System and one MiniSpace FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937003620 FDA UDI
- 510(k) Number
- K974819 FDA UDI
- FDA Product Code
- HHK FDA UDI
- GMDN Term
- Spermatozoa/semen motility medium supplement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Spermatozoa/semen motility medium supplement
SpermSelect Mini Kit by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spermatozoa/semen motility medium supplement.
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- Nidacon — Nidacon International AB · Class II
- Enhance-S Plus — Vitrolife AB · Class II
- Nidacon — Nidacon International AB · Class II
- Enhance Sperm Wash w/ Gentamicin — Vitrolife AB · Class II
- Nidacon — Nidacon International AB · Class I
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
- CooperSurgical, Inc.
Sources (1)
- FDA UDI cce28003-7cc4-4084-b08d-d881533ac842 34 fields · synced Jun 9, 2026