Stellarex™ AB35SX050120135

GUDID 00813132023225

Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon

Spectranetics 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 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 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 ID00813132023225
NIH Device Record Keyab7843d5-32f3-4970-a899-9cc9347a70e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameStellarex™
Version Model NumberAB35SX050120135
Catalog NumberAB35SX050120135
Company DUNS151047370
Company NameSpectranetics 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 Datefalse
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
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.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
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
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

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Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Outer Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter
Balloon Diameter5 Millimeter
Balloon Length120 Millimeter
Catheter Length135 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; keep away from sunlight
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 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 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
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
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
GS100813132023225 [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 Number6
Public Version Date2020-02-27
Device Publish Date2017-07-27

On-Brand Devices [Stellarex™]

00813132025021Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132025014Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132025007Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132024994Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132024987Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132024970Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132024291Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132024284Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132024277Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132024260Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132024253Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132024246Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023256Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023249Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023232Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023225Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023218Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023201Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023195Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023188Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023171Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023164Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023157Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023140Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023133Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023126Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023119Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023102Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023096Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132023089Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132026981Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132026974Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132026967Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132026950Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132026707Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132026691Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132026622Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132026615Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132026547Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132026530Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132026462Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
00813132026455Stellarex™ 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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