Identity
- Trade Name
- GPS User Kit EUDAMEDEXACTECHGPS FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Device Name
- GPS User Kit EUDAMEDIMPLANT KIT FDA UDI
- Model / Reference
- A10012 EUDAMEDFDA UDI
- Description
- IMPLANT KIT FDA UDI
Identifiers
- Catalog Number
- A10012 FDA UDI
- Primary DI / UDI-DI
- 10885862266651 EUDAMEDFDA UDI
- Basic UDI-DI
- 10885862100216NZ EUDAMED
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Robotic surgical navigation system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Medical Purpose
- The GPS user kit is indicated to be used with the Blue Ortho navigation system during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
GPS User Kit by Blue Ortho SAS — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 10885862100216NZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Blue Ortho SAS
- EUDAMED SRN
- FR-PR-000036416
Sources (2)
- EUDAMED 6c709bfb-9721-4603-bd70-41318b55fd11 61 fields · synced Jul 9, 2026
- FDA UDI e74ef049-ac65-4b01-83dd-f6780961228e 36 fields · synced May 30, 2026