Identity
- Trade Name
- SurgiCase FDA UDI
- Generic Name
- Custom-made organ/bone anatomy model FDA UDI
- Device Name
- HeartPrint anatomical model FDA UDI
- Model / Reference
- H-00-8-770000-0001-000 FDA UDI
- Description
- HeartPrint anatomical model FDA UDI
Identifiers
- Catalog Number
- H-00-8-770000-0001-000 FDA UDI
- Primary DI / UDI-DI
- E314H0087700000001000 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
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 98cd29e6-ae5a-4608-851b-1f4f227a7dc9 35 fields · synced May 31, 2026