Identity
- Trade Name
- SurgiCase FDA UDI
- Generic Name
- Custom-made organ/bone anatomy model FDA UDI
- Device Name
- Anatomical model, Pediatric FDA UDI
- Model / Reference
- UEA-MA10-00-01 FDA UDI
- Description
- Anatomical model, Pediatric FDA UDI
Identifiers
- Catalog Number
- UEA-MA10-00-01 FDA UDI
- Primary DI / UDI-DI
- E314UEAMA1000010 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Custom-made organ/bone anatomy model FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
SurgiCase by Materialise NV — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Materialise NV
Sources (1)
- FDA UDI 9f87576c-5873-4a8d-a426-aa7c597982db 35 fields · synced May 30, 2026