FDA.reportPublic FDA data

Instrument clamp 2-6 mm

Primary DI
B057U1017010
Brand
Instrument clamp 2-6 mm
Company
Scopis GmbH
Model
1.0
Catalog number
U1 017 01
Device description
The Instrument clamp 2-6 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To track the location of compatible surgical instruments an instrument clamp with appropriate diameter is fixed to a rigid portion of the instrument and equipped with a Universal tracker EM.Instrument clamps are provided non-sterile and are intended to be sterilized by the user.Instrument clamps are reusable.
Published
2018-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
B057U1017010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation device tracking system spatial register connectorA non-sterile component of a surgical navigation device tracking system (e.g., optical device tracking system, electromagnetic device tracking system) intended to connect the system’s spatial register [localizer/tracker/calibrator (e.g., infrared light reflector)] to a navigated surgical instrument (e.g., a stereotactic surgery system probe, dental drill), and/or to a navigation fiducial marker, during computer assisted surgery (CAS); it may be affixed via dedicated screws. It is typically made of metallic or polymer materials and may be in the shape of a handle to facilitate handling the instrument during a procedure. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
341702266
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
B057U1038020Calibration body EM1.0U1 038 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
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