Identity
- Trade Name
- IMPIX 3D Print FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Lamina spreader FDA UDI
- Model / Reference
- A24600100 FDA UDI
- Description
- Lamina spreader FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03613720270805 FDA UDI
- 510(k) Number
- K163595 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Moist Heat or Steam Sterilization FDA UDI
IMPIX 3D Print by Medicrea International SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K163595 also covers:
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
- Medicrea International SA
Sources (1)
- FDA UDI 3a9da87d-7e31-42ab-ad53-d8fb55b09c05 35 fields · synced May 31, 2026