Identity
- Trade Name
- Patient tracker EM mini FDA UDI
- Generic Name
- Patient positioning sensor FDA UDI
- Device Name
- The Patient Tracker EM mini provides a reference point on the patient. This reference defines the patient location and is used to correlate the patient anatomy to the image set. The Patient Tracker connects to the Navigation Unit via an integrated cable. The Patient Tracker EM mini is provided non-sterile and is intended to be sterilized by the user. The Patient Tracker EM mini is reusable. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- The Patient Tracker EM mini provides a reference point on the patient. This reference defines the patient location and is used to correlate the patient anatomy to the image set. The Patient Tracker connects to the Navigation Unit via an integrated cable. The Patient Tracker EM mini is provided non-sterile and is intended to be sterilized by the user. The Patient Tracker EM mini is reusable. FDA UDI
Identifiers
- Catalog Number
- U1 031 12 FDA UDI
- Primary DI / UDI-DI
- B057U1031120 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
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Patient positioning sensor
Patient tracker EM mini by Scopis GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient positioning sensor.
- NGENIUS — Stryker Leibinger · Class II
- EV1000 — Edwards Lifesciences LLC · Class II
- Sherlock — Bard Access Systems, Inc. · Class II
- V40 — MAKO Surgical Corp. · Class II
- General Purpose Sensor — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Scopis GmbH
Sources (1)
- FDA UDI f04a3fb4-ce7b-4803-a2b6-1d46d2df2a52 34 fields · synced May 29, 2026