AccessGUDID - DEVICE: Auryon Atherectomy Catheter (07290017590325)

GUDID

Device Identifier (DI) Information

Brand Name: Auryon Atherectomy Catheter
Version or Model: EXM-4012-H000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EXM-4012-H000
Company Name: EXIMO MEDICAL LTD

Primary DI Number: 07290017590325
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600468941 *Terms of Use

Device Description: Auryon Atherectomy Catheter 1.7mm - Hydrophilic Coated

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?
43229	Atherectomy laser system beam guide-catheter, peripheral	A sterile, flexible tube intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the peripheral vasculature for the intraluminal photoablation or debulking of lesion material (blockages or total occlusions), to re-establish blood flow within the vessel. It typically consists of fibreoptic materials with a laser-firing distal end and may be designed for over-the-wire (OTW) or rapid exchange insertion. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCW	Catheter, Peripheral, Atherectomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241553	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
Storage Environment Temperature: between -18 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 1.7 Millimeter
Length: 150 Centimeter

Device Record Status

Public Device Record Key: e165eeed-5a0f-4edb-878b-79803da5cc5b
Public Version Date: November 05, 2024
Public Version Number: 2
DI Record Publish Date: September 16, 2024