Identity
- Trade Name
- Field generator planar FDA UDI
- Generic Name
- Patient positioning sensor FDA UDI
- Device Name
- The Scopis Hybrid Navigation System EM utilizes the Field Generator planar to create the electromagnetic field for navigation of surgical instruments. The EM Field Generator planar is connected to a mounting arm for placement close to the surgical area. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- The Scopis Hybrid Navigation System EM utilizes the Field Generator planar to create the electromagnetic field for navigation of surgical instruments. The EM Field Generator planar is connected to a mounting arm for placement close to the surgical area. FDA UDI
Identifiers
- Catalog Number
- U3 010 01 FDA UDI
- Primary DI / UDI-DI
- B057U3010010 FDA UDI
- FDA Product Code
- PGW FDA UDI
- GMDN Term
- Patient positioning sensor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Patient positioning sensor
Field generator planar by Scopis GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient positioning sensor.
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- Sherlock — Bard Access Systems, Inc. · Class II
- Calibration End Effector Inverted — MAKO Surgical Corp. · Class II
- Sherlock — Bard Access Systems, Inc. · Class II
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
- Scopis GmbH
Sources (1)
- FDA UDI c180edc1-4adb-49de-8dbd-ae6d44000050 34 fields · synced May 30, 2026