Primary Device ID | 00813132024246 |
NIH Device Record Key | 3d8e701f-b44e-4ea9-906b-2901ef18db48 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Stellarex™ |
Version Model Number | AB35SX040060080 |
Catalog Number | AB35SX040060080 |
Company DUNS | 151047370 |
Company Name | Spectranetics Corporation |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | true |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Outer Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Balloon Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Balloon Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Balloon Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Balloon Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Balloon Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Balloon Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Balloon Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Balloon Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Balloon Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Balloon Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Balloon Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Balloon Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Balloon Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Balloon Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Balloon Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Balloon Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Balloon Diameter | 4 Millimeter |
Balloon Length | 60 Millimeter |
Catheter Length | 80 Centimeter |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry; keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00813132024246 [Primary] |
ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 6 |
Public Version Date | 2020-02-27 |
Device Publish Date | 2017-07-27 |
00813132025021 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132025014 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132025007 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132024994 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132024987 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132024970 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132024291 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132024284 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132024277 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132024260 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132024253 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132024246 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023256 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023249 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023232 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023225 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023218 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023201 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023195 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023188 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023171 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023164 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023157 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023140 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023133 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023126 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023119 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023102 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023096 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132023089 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132026981 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132026974 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132026967 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132026950 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132026707 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132026691 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132026622 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132026615 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132026547 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132026530 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132026462 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
00813132026455 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
STELLAREX 98281976 not registered Live/Pending |
Pitcher, Charles Spencer 2023-11-22 |
STELLAREX 85958731 4993727 Live/Registered |
Covidien LP 2013-06-13 |