AccessGUDID - DEVICE: CerebroFlo EVD Catheter Set (10866614000105)

GUDID

Device Identifier (DI) Information

Brand Name: CerebroFlo EVD Catheter Set
Version or Model: 37.550.501
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 37.550.501
Company Name: ARKIS BIOSCIENCES INC.

Primary DI Number: 10866614000105
Issuing Agency: GS1
Commercial Distribution End Date: August 26, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 078846878 *Terms of Use

Device Description: The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through the drainage holes near the catheter's tip. The catheter is barium-sulfate impregnated to provide radiopacity. The CerebroFlo EVD Catheter is provided with a Stylette, Trocar, Barbed Leur Connector, Male Leur Cap, and a suture clip.

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):	Yes
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?
61399	Intracerebral infusion/drainage catheter, short-term	A flexible tube intended to be surgically inserted through the skull for short-term (= 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it may also be intended for measurement of intracranial pressure (ICP). It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, bolts, drills, catheter holder); it does not include a sensor. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JXG	Shunt, Central Nervous System And Components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170599	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 35 Centimeter
Outer Diameter: 3.3 Millimeter

Device Record Status

Public Device Record Key: b3a38145-55be-4f7a-a6b1-f4cb46fdd2e4
Public Version Date: March 26, 2024
Public Version Number: 6
DI Record Publish Date: October 24, 2019