Identity
- Trade Name
- Modified Ham's F-10 with Albumin FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Modified Ham's F-10 w/Albumin FDA UDI
- Model / Reference
- 99109-12X12ML FDA UDI
- Description
- Modified Ham's F-10 w/Albumin FDA UDI
Identifiers
- Catalog Number
- 99109 FDA UDI
- Primary DI / UDI-DI
- 00893727002934 FDA UDI
- 510(k) Number
- K991420 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
- Not 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
Yes
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 — 12 Milliliter FDA UDI
Modified Ham's F-10 with Albumin by Fujifilm Irvine Scientific, 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
- Fujifilm Irvine Scientific, Inc.
Sources (1)
- FDA UDI 4f85a83b-d206-4788-8746-1824db22c4f9 39 fields · synced May 30, 2026