70 Brain Microdialysis Catheter 60/10, 4/pkg P000049

GUDID 07332699000546

Microdialysis catheter (20 kDa cut-off, 60 mm shaft length, 10 mm membrane length) for short term brain insertion using a tunnelation technique.

M DIALYSIS INC.

Microdialysis system catheter
Primary Device ID07332699000546
NIH Device Record Key8f1aaa2c-d9f1-40a9-941e-07cded038fbf
Commercial Distribution StatusIn Commercial Distribution
Brand Name70 Brain Microdialysis Catheter 60/10, 4/pkg
Version Model Number60/10
Catalog NumberP000049
Company DUNS824632087
Company NameM DIALYSIS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Length10 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107332699000546 [Package]
Contains: 07332699000911
Package: White cardboard box [4 Units]
In Commercial Distribution
GS107332699000911 [Primary]

FDA Product Code

GWMDevice, Monitoring, Intracranial Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-07
Device Publish Date2016-09-24

Devices Manufactured by M DIALYSIS INC.

07332699000300 - Reagent Kit2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate and Glycerol.
07332699000331 - Reagent Set A2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate and Glycerol mounted in a
07332699000348 - Reagent Set B2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate, Glycerol and Glutamate m
07332699000355 - Reagent Set C2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate and Pyruvate mounted in a cassette.
07332699000461 - Calibrator A2019-10-07 Calibrator for ISCUSflex Microdialysis Analyzer. Contains calibrator levels for Glucose, Lactate, Pyruvate, Glycerol and Glutama
07332699000744 - ISCUSflex2019-10-07 Microdialysis analyzer using substance specific reagents to evaluate the concentrations in the samples given by the Microdialysi
07332699000621 - L-P-G Reagent kit2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate and Pyruvate.
07332699000546 - 70 Brain Microdialysis Catheter 60/10, 4/pkg2019-10-07Microdialysis catheter (20 kDa cut-off, 60 mm shaft length, 10 mm membrane length) for short term brain insertion using a tunnelation technique.
07332699000546 - 70 Brain Microdialysis Catheter 60/10, 4/pkg2019-10-07 Microdialysis catheter (20 kDa cut-off, 60 mm shaft length, 10 mm membrane length) for short term brain insertion using a tunnel

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