Identity
- Trade Name
- Signature FDA UDI
- Generic Name
- Custom-made organ/bone anatomy model FDA UDI
- Device Name
- SIGNATURE XP BONE MODELS FDA UDI
- Model / Reference
- 42-433410 FDA UDI
- Description
- SIGNATURE XP BONE MODELS FDA UDI
Identifiers
- Catalog Number
- 42-433410 FDA UDI
- Primary DI / UDI-DI
- E314424334100 FDA UDI
- 510(k) Number
- K140257 FDA UDI
- FDA Product Code
- JWH FDA UDIMBH FDA UDIOOG FDA UDIOIY FDA UDIMBV FDA UDI
- GMDN Term
- Custom-made organ/bone anatomy model FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3565 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
No
FDA UDI
Signature by Materialise NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 a8202689-1a5e-4a4c-8e64-17f5d79a1dab 36 fields · synced May 30, 2026