AccessGUDID - DEVICE: Phoenix 1.5mm x 149cm 4F Atherectomy Catheter (00845225003166)

GUDID

Device Identifier (DI) Information

Brand Name: Phoenix 1.5mm x 149cm 4F Atherectomy Catheter
Version or Model: P15149
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P15149
Company Name: Volcano Atheromed, Inc.

Primary DI Number: 00845225003166
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 788341084 *Terms of Use

Device Description: No description.

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?
44307	Mechanical atherectomy system catheter, peripheral	A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. 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 [?]
K211518	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
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 1.5 Millimeter
Length: 149 Centimeter

Device Record Status

Public Device Record Key: fe045838-b4e9-4e41-9165-9f596b261844
Public Version Date: August 21, 2024
Public Version Number: 4
DI Record Publish Date: October 26, 2021