Stellarex™ AB35SX050060135

GUDID 00813132029043

Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon

Philips Image Guided Therapy Corporation

Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated
Primary Device ID00813132029043
NIH Device Record Keya0b451d2-6821-4ef2-b69c-3906151942ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameStellarex™
Version Model NumberAB35SX050060135-A
Catalog NumberAB35SX050060135
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

Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com
Phone1-800-231-0978
EmailSPNC-complaints@philips.com

Device Dimensions

Balloon Proximal Outer Diamete5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Proximal Outer Diamete5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Proximal Outer Diamete5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Proximal Outer Diamete5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Proximal Outer Diamete5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Proximal Outer Diamete5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Proximal Outer Diamete5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Proximal Outer Diamete5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Proximal Outer Diamete5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Proximal Outer Diamete5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Proximal Outer Diamete5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Proximal Outer Diamete5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Proximal Outer Diamete5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Proximal Outer Diamete5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length60 Millimeter
Catheter Length135 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; keep away from sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; keep away from sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; keep away from sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; keep away from sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; keep away from sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; keep away from sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; keep away from sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; keep away from sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; keep away from sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; keep away from sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; keep away from sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; keep away from sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; keep away from sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; keep away from sunlight
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100813132029043 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-21
Device Publish Date2022-01-13

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00813132029173Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132029166Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132029159Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132029142Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132029135Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132029128Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132029111Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132029104Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132029098Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132029081Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132029074Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132029067Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132029050Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132029043Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132029036Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132029029Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132029012Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132029005Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028992Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028985Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028978Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028961Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028954Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028947Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028930Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028923Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028916Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028909Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028893Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028886Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028879Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028862Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028855Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028848Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028831Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028817Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028800Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028794Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028787Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028770Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132028763Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon

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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