Identity
- Trade Name
- TrueSight FDA UDI
- Generic Name
- Custom-made organ/bone anatomy model/surgical guide kit FDA UDI
- Device Name
- TSA guide and bone model FDA UDI
- Model / Reference
- 5901-6201 FDA UDI
- Description
- TSA guide and bone model FDA UDI
Identifiers
- Catalog Number
- 5901-6201 FDA UDI
- Primary DI / UDI-DI
- 05420060362019 FDA UDI
- FDA Product Code
- KWS FDA UDIQHE FDA UDIPHX FDA UDI
- GMDN Term
- Custom-made organ/bone anatomy model/surgical guide kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 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
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
TrueSight by Materialise NV — 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
- Materialise NV
Sources (1)
- FDA UDI 06e22aad-6b8f-48c5-8b15-774350a7174b 35 fields · synced May 30, 2026