Identity
- Trade Name
- EmbedMed FDA UDI
- Generic Name
- Custom-made organ/bone anatomy model FDA UDI
- Device Name
- Patient-specific, Maxillofacial Anatomical Model, Digital FDA UDI
- Model / Reference
- CMFDAM FDA UDI
- Description
- Patient-specific, Maxillofacial Anatomical Model, Digital FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009815735 FDA UDI
- FDA Product Code
- LLZ FDA UDIDZJ FDA UDI
- GMDN Term
- Custom-made organ/bone anatomy model FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI872.4120 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
EmbedMed by 3D Lifeprints UK , Ltd. — 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
- 3D Lifeprints UK , Ltd.
Sources (1)
- FDA UDI 8c9034d6-6ffc-4bf7-8e2b-554ff6b3d13a 34 fields · synced May 30, 2026