FDA.reportPublic FDA data

Calibration body EM

Primary DI
B057U1038020
Brand
Calibration body EM
Company
Scopis GmbH
Model
1.0
Catalog number
U1 038 02
Device 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.
Published
2018-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
PGWEar, Nose, And Throat Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGWEar, Nose, And Throat Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B057U1038020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic surgical navigation/tracking systemAn assembly of devices intended for tracking spatial markers attached to a surgical instrument(s) and/or the patient, based on movement through a variable electromagnetic (EM) field. It is designed to generate visual diagrams of the relative position/orientation of the instrument/marker during surgery and may additionally allow surgical navigation through overlay of radiological images [e.g., ultrasound (US)]. It consists of a console with display and an EM field generator/receiver; spatial markers, instruments, a foot switch, or trolley may in addition be packaged with the system. It is intended for use during multiple types of surgical procedure (e.g., breast, gastrointestinal, lung).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
341702266
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B057U1017010Instrument clamp 2-6 mm1.0U1 017 012018-01-04
B057U1017020Instrument clamp forceps1.0U1 017 022018-01-04
B057U1017030Instrument clamp 6-10 mm1.0U1 017 032018-01-04
B057U1017050Instrument clamp 10-16 mm1.0U1 017 052018-01-04
B057U1029010Precision Pointer EM1.0U1 029 012018-01-04
B057U1029030Registration pointer EM-D1.0U1 029 032018-01-04
B057U1030110Suction tube Frazier EM1.0U1 030 112018-01-04
B057U1030120Suction tube Eicken EM1.0U1 030 122018-01-04
B057U1037020Endoscope tracker EM1.0U1 037 022018-01-04
B057U1046020Universal Tracker EM1.0U1 046 022018-01-04
B057U1049010Instrument port1.0U1 049 012018-01-04
B057U1085400Instrument clip 4 mm1.0U1 085 402018-01-04
B057U2040040Hybrid Navigation Unit EM2.2U2 040 042018-01-04
B057U9020010Patient tracker tabs (PU 100)1.0U9 020 012018-01-04
B057U4003260170NOVA AR2.6.17U4 0032018-04-20
B057U1031120Patient tracker EM mini1.0U1 031 122018-01-04
B057U1031300Patient tracker EM-D mini1.0U1 031 302018-01-04
B057U3010010Field generator planar1.0U3 010 012018-01-04
B057U3011010Field generator mounting arm1.0U3 011 012018-01-04
B057U40030NOVA AR2.6.15U4 0032018-01-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000768744StealthStation S8MEDTRONIC NAVIGATION, INC.PGW2023-11-27