Identity
- Trade Name
- SpermFreeze FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- SpermFreeze SpermFreeze is a medium for the cryopreservation of human spermatozoa. SpermFreeze has a shelf life of 18 months. For the most recent information about the product specifications, instructions for use and MSDS, reference is made to the FertiPro website (www.fertipro.com) FDA UDI
- Model / Reference
- SPF05 FDA UDI
- Description
- SpermFreeze SpermFreeze is a medium for the cryopreservation of human spermatozoa. SpermFreeze has a shelf life of 18 months. For the most recent information about the product specifications, instructions for use and MSDS, reference is made to the FertiPro website (www.fertipro.com) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05411967002016 FDA UDI
- 510(k) Number
- K053494 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- IVF medium FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 5 Milliliter FDA UDI
Category: IVF medium
SpermFreeze by Fertipro NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as IVF medium.
- SPERMCARE Upper Layer - Gradient System — INVITROCARE, INCORPORATED · Class II
- DEWIN — DonneVie Medical Technology(Shanghai)Co.Ltd · Class II
- Sepa Sperm Solution — KITAZATO CORPORATION · Class II
- LifeGlobal® Media — LifeGlobal Group, LLC · Class II
- Multipurpose Handling Medium®-Complete (MHM®-C) — FUJIFILM IRVINE SCIENTIFIC, INC. · Class II
- CaseBioscience® — Casebioscience, Inc. · Class II
- Gems Blastocyst Medium — GENEA BIOMEDX PTY LTD · Class II
- Sperm Freezing Medium — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II
Cleared under the same submission
K053494 also covers:
- Sil-Select Stock — Fertipro NV
- Sil-Select Stock — Fertipro NV
- Sil-Select Stock — Fertipro NV
- SpermFreeze — Fertipro NV
- SpermFreeze SSP — Fertipro NV
- SpermFreeze SSP — Fertipro NV
- SpermFreeze SSP — Fertipro NV
- SpermFreeze SSP — Fertipro NV
- GM501 Gradient 100% — HAMILTON THORNE, Inc.
- GM501 Gradient 100% — HAMILTON THORNE, Inc.
- GM501 Gradient 100% — HAMILTON THORNE, Inc.
- GM501 Gradient 100% — HAMILTON THORNE, Inc.
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
- Fertipro NV
Sources (1)
- FDA UDI 899e00cf-b86d-463c-8d1e-2bedde7f46d6 37 fields · synced May 30, 2026