FDA.report

N/A

Primary DI
EINO5907109
Brand
N/A
Company
inomed Medizintechnik GmbH
Model
590710
Device description
Connecting cable 5 channels for micro and macro electrodes
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GZLElectrode, Depth

Product Code Classifications

CodeDeviceSpecialtyClass
GZLElectrode, DepthNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EINO5907109PrimaryHIBCC0

GMDN Terms

TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
340782259
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

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