Home GUDID 37613252731437 SPINEMASK
Primary DI 37613252731437
Brand SPINEMASK
Company Stryker Leibinger GmbH & Co. KG
Model 6002-390-000
Catalog number 6002-390-000
Device description SPINEMASK (TM) TRACKER
Published 2016-09-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name OLO Orthopedic stereotaxic instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OLO Orthopedic Stereotaxic Instrument Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 37613252731437 Primary GS1 0 07613252731436 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 37613252731437 37613252731437 07613252731436 07613252731436 7613252731436
GMDN Terms# Term, Definition table Term Definition Imaging lesion localization marker, external, single-use A device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Height 25 Millimeter Length 377 Millimeter Width 255 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 30 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 35 Degrees Celsius Special Storage Condition, Specify 0 0 -20 Degrees Celsius to 70 Degrees Celsius Special Storage Condition, Specify 0 0 50-106KPA Special Storage Condition, Specify 0 0 TRANSPORT -20 DEGREES CELSIUS TO 70 DEGREES CELSIUS Special Storage Condition, Specify 0 0 Transport 10-90 Percent Special Storage Condition, Specify 0 0 TRANSPORT 10-90 PERCENT HUMIDITY Special Storage Condition, Specify 0 0 TRANSPORT: 10-90%, 50-106HPA,-20+70¿C Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 30 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature 4 Degrees Celsius 35 Degrees Celsius
Regulatory Flags# DUNS number 316153956 Device count 2 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes#