Home GUDID M610311081 Integra
Primary DI M610311081
Brand Integra
Company INTEGRA PAIN MANAGEMENT
Model 31108
Device description Combo Kit Consists OF 10-110/INS-4500/INS-7260
Published 2016-12-29
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 true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10381780178170 Primary GS1 0 M610311081 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780178170 10381780178170
GMDN Terms# Term, Definition table Term Definition Ventricular cerebrospinal fluid drainage catheterization kit A collection of sterile devices intended for short-term access to the brain ventricles to drain cerebrospinal fluid (CSF) as a means of reducing CSF volume and intracranial pressure (ICP). It includes an intracerebral infusion/drainage catheter and devices intended for catheter insertion (e.g. stylet) and CSF collection (e.g., drip chamber, drainage bag, tubing set). This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 20 Degrees Celsius 25 Degrees Celsius Storage Environment Temperature 68 Degrees Fahrenheit 77 Degrees Fahrenheit
Regulatory Flags# DUNS number 030370299 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product true Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# 
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