Stellarex AB35SX060100080

GUDID 00810060550359

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

Philips Image Guided Therapy Corporation

Peripheral angioplasty balloon catheter, drug-coated
Primary Device ID00810060550359
NIH Device Record Key0f487dbc-e5fa-4e60-b10b-c6647c1a23a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameStellarex
Version Model NumberAB35SX060100080-B
Catalog NumberAB35SX060100080
Company DUNS118354223
Company NamePhilips Image Guided Therapy Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com

Device Dimensions

Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter
Balloon Diameter6 Millimeter
Balloon Length100 Millimeter
Catheter Length80 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100810060550359 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONUDrug-Eluting Peripheral Transluminal Angioplasty Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-08-17
Device Publish Date2022-12-30

On-Brand Devices [Stellarex]

00813132028824Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 40mm) x 80cm
00810060550427Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 200mm) x 135cm
00810060550410Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 200mm) x 80cm
00810060550403Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 150mm) x 135cm
00810060550397Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 150mm) x 80cm
00810060550380Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 120mm) x 135cm
00810060550373Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 120mm) x 80cm
00810060550366Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 100mm) x 135cm
00810060550359Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 100mm) x 80cm
00810060550342Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 80mm) x 135cm
00810060550335Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 80mm) x 80cm
00810060550328Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 60mm) x 135cm
00810060550311Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 60mm) x 80cm
00810060550304Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 40mm) x 135cm
00810060550298Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 40mm) x 80cm
00810060550281Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 200mm) x 135cm
00810060550274Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 200mm) x 80cm
00810060550267Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 150mm) x 135cm
00810060550250Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 150mm) x 80cm
00810060550243Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 120mm) x 135cm
00810060550236Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 120mm) x 80cm
00810060550229Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 100mm) x 135cm
00810060550212Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 100mm) x 80cm
00810060550205Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 80mm) x 135cm
00810060550199Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 80mm) x 80cm
00810060550182Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 60mm) x 135cm
00810060550175Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 60mm) x 80cm
00810060550168Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 40mm) x 135cm
00810060550151Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 40mm) x 80cm
00810060550144Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 200mm) x 135cm
00810060550137Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 200mm) x 80cm
00810060550120Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 150mm) x 135cm
00810060550113Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 150mm) x 80cm
00810060550106Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 120mm) x 135cm
00810060550090Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 120mm) x 80cm
00810060550083Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 100mm) x 135cm
00810060550076Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 100mm) x 80cm
00810060550069Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 80mm) x 135cm
00810060550052Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 80mm) x 80cm
00810060550045Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 60mm) x 135cm
00810060550038Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 60mm) x 80cm
00810060550021Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 40mm) x 135cm
00810060550014Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 40mm) x 80cm

Trademark Results [Stellarex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STELLAREX
STELLAREX
98281976 not registered Live/Pending
Pitcher, Charles Spencer
2023-11-22
STELLAREX
STELLAREX
85958731 4993727 Live/Registered
Covidien LP
2013-06-13

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