AccessGUDID - DEVICE: Cleaner XT™ Rotational Thrombectomy System (00886333222322)

GUDID

Device Identifier (DI) Information

Brand Name: Cleaner XT™ Rotational Thrombectomy System
Version or Model: 700109XT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 700109XT
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333222322
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: Cleaner XT™ Rotational Thrombectomy System 6F x 135cm

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:	No
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?
58172	Thrombectomy rotational catheter	A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing acute vascular obstruction in native and stented blood vessels, or in native and synthetic bypass or haemodialysis access grafts, through a mechanical rotational action intended to erode and aspirate the obstruction for removal. It typically consists of a rotational catheter body/head powered by a magnetic power transmission provided by a connected control unit; ancillary device such as catheter guidewires, sterile cable covers, and collecting bags may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRA	Catheter, Continuous Flush

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
Special Storage Condition, Specify: Type B Applied Part
Special Storage Condition, Specify: Keep Dry and Away from Sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 6F x 135cm

Device Record Status

Public Device Record Key: cb8415be-3478-4ad1-8375-8ca651c772b4
Public Version Date: September 13, 2018
Public Version Number: 3
DI Record Publish Date: September 12, 2016