Identity
- Trade Name
- ADAS 3D FDA UDI
- Generic Name
- Surgical simulation system FDA UDI
- Model / Reference
- V2.8 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437021722031 FDA UDI
- 510(k) Number
- K210850 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Surgical simulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical simulation system
Adas 3d by Adas3d Medical S.l. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical simulation system.
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- 3D-SHAPER — 3D-SHAPER MEDICAL S.L. · Class II
- ADAS 3D — ADAS3D MEDICAL S.L. · Class II
- ADAS 3D — ADAS3D MEDICAL S.L. · Class II
- ADAS 3D — ADAS3D MEDICAL S.L. · Class II
Cleared under the same submission
K210850 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
- Adas3d Medical S.l.
Sources (1)
- FDA UDI b7c2602c-b79e-4b90-a728-4e5c124a7014 33 fields · synced Jun 8, 2026