Stellarex™ AB35SX060100135
GUDID 00813132025021
Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon
Spectranetics Corporation
Peripheral angioplasty balloon catheter, drug-coated| Primary Device ID | 00813132025021 |
| NIH Device Record Key | c02c6fe3-a1eb-497c-84f2-ce3d64c63d4b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stellarex™ |
| Version Model Number | AB35SX060100135 |
| Catalog Number | AB35SX060100135 |
| 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 |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Outer Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 100 Millimeter |
| Catheter Length | 135 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813132025021 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-02-27 |
| Device Publish Date | 2017-12-11 |
On-Brand Devices [Stellarex™]
| 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 |
Trademark Results [Stellarex]
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 |
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