Identity
- Trade Name
- Clear-Site® FDA UDI
- Generic Name
- Laser patient positioning system FDA UDI
- Device Name
- EDMS 46918 CLEAR-SITE LASER LEVEL FDA UDI
- Model / Reference
- 46918 FDA UDI
- Description
- EDMS 46918 CLEAR-SITE LASER LEVEL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000281267 FDA UDI
- 510(k) Number
- DEN120017 FDA UDI
- FDA Product Code
- PCB FDA UDI
- GMDN Term
- Laser patient positioning system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5560 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Laser patient positioning system
Clear-Site® by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
DEN120017 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic PS Medical
Sources (1)
- FDA UDI 30cfc284-2dae-47ca-8fdf-7af35ffb7dce 35 fields · synced May 30, 2026