Identity
- Trade Name
- Modified Ham's F-10 Basal Medium FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Modified Ham's F-10 FDA UDI
- Model / Reference
- 99175-100ML FDA UDI
- Description
- Modified Ham's F-10 FDA UDI
Identifiers
- Catalog Number
- 99175 FDA UDI
- Primary DI / UDI-DI
- 00893727002958 FDA UDI
- FDA Product Code
- HDR FDA UDI
- GMDN Term
- IVF medium FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5250 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 100 Milliliter FDA UDI
Category: IVF medium
Modified Ham's F-10 Basal Medium by Fujifilm Irvine Scientific, Inc. — 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
- CaseBioscience® — Casebioscience, Inc. · Class II
- SpermFreeze SSP — Fertipro NV · Class II
- Gems Blastocyst Medium — GENEA BIOMEDX PTY LTD · Class II
- Sperm Freezing Medium — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fujifilm Irvine Scientific, Inc.
Sources (1)
- FDA UDI d101fef5-0b88-4f57-96b1-efb9e19cac99 37 fields · synced Jun 8, 2026