AccessGUDID - DEVICE: Stellarex (00813132028800)

GUDID

Device Identifier (DI) Information

Brand Name: Stellarex
Version or Model: AB35SX060100080
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AB35SX060100080
Company Name: Philips Image Guided Therapy Corporation

Primary DI Number: 00813132028800
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118354223 *Terms of Use

Device Description: Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 100mm) x 80cm

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:	Yes
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?
62551	Peripheral angioplasty balloon catheter, drug-coated	A sterile, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip, and to simultaneously release a drug intended to inhibit restenosis; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single-lumen. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ONU	Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160049	012

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 away from sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
Balloon Diameter: 6 Millimeter
Balloon Length: 100 Millimeter
Catheter Length: 80 Centimeter

Device Record Status

Public Device Record Key: 995b4dc3-016b-4fb1-8c19-a2e65c4e4431
Public Version Date: June 25, 2024
Public Version Number: 3
DI Record Publish Date: January 13, 2022