AccessGUDID - DEVICE: 70 Brain Microdialysis Catheter 60/10, 4/pkg (07332699000911)

GUDID

Device Identifier (DI) Information

Brand Name: 70 Brain Microdialysis Catheter 60/10, 4/pkg
Version or Model: 60/10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P000049
Company Name: M DIALYSIS INC.

Primary DI Number: 07332699000911
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 824632087 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45469	Microdialysis system catheter	A thin, flexible tube intended to be inserted/implanted into tissue (e.g., brain, liver, muscle) as part of a system used to monitor local tissue chemistry for the early detection of metabolic imbalances and/or cell damage, typically after surgery or during a metabolic disorder. The device has a semi-permeable membrane at its distal end for the diffusion of interstitial fluid to obtain a dialysate sample for analysis. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWM	Device, Monitoring, Intracranial Pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 10 Millimeter

Device Record Status

Public Device Record Key: 8f1aaa2c-d9f1-40a9-941e-07cded038fbf
Public Version Date: October 07, 2019
Public Version Number: 3
DI Record Publish Date: September 24, 2016