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Calibration body EM

FDA UDI

Class II (US FDA UDI)

by Scopis GmbH

Identity

Trade Name
Calibration body EM FDA UDI
Generic Name
Electromagnetic surgical navigation device tracking system FDA UDI
Device Name
The Calibration body EM is used to calibrate a surgical endoscope which is tracked with Endoscope tracker EM. The location of the Calibration Body EM is referenced relative to the Endoscope tracker EM and allows Navigation Software NOVA AR to compute the optical parameters of the attached surgical endoscope. The Calibration body EM connects to the Hybrid Navigation Unit EM via an integrated cable. The Calibration body EM is provided non-sterile and is intended to be sterilized by the user. The Calibration body EM is reusable. FDA UDI
Model / Reference
1.0 FDA UDI
Description
The Calibration body EM is used to calibrate a surgical endoscope which is tracked with Endoscope tracker EM. The location of the Calibration Body EM is referenced relative to the Endoscope tracker EM and allows Navigation Software NOVA AR to compute the optical parameters of the attached surgical endoscope. The Calibration body EM connects to the Hybrid Navigation Unit EM via an integrated cable. The Calibration body EM is provided non-sterile and is intended to be sterilized by the user. The Calibration body EM is reusable. FDA UDI

Identifiers

Catalog Number
U1 038 02 FDA UDI
Primary DI / UDI-DI
B057U1038020 FDA UDI
FDA Product Code
PGW FDA UDI
GMDN Term
Electromagnetic surgical navigation device tracking system 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electromagnetic surgical navigation device tracking system

Calibration body EM by Scopis GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromagnetic surgical navigation device tracking system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scopis GmbH

Sources (1)

  • FDA UDI 6b17dc8b-6eda-46db-bb09-abca5f2607f7 34 fields · synced May 30, 2026