Lutonix ®Drug Coated Balloon LX3575560
GUDID 00801741088032
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x60mm
LUTONIX, INC.
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 ID | 00801741088032 |
| NIH Device Record Key | 1fe24f1c-5ad2-44cf-bb92-cbe0036f7ddb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lutonix ®Drug Coated Balloon |
| Version Model Number | LX3575560 |
| Catalog Number | LX3575560 |
| Company DUNS | 946734808 |
| Company Name | LUTONIX, INC. |
| 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
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741088032 [Primary] |
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 | 4 |
| Public Version Date | 2019-09-04 |
| Device Publish Date | 2014-10-23 |
Devices Manufactured by LUTONIX, INC.
| 00801741202575 - Lutonix 035 Drug Coated Balloon PTA Catheter | 2020-02-11 Lutonix 035 12X60MMx75CM |
| 00801741187636 - LUTONIX® Drug Coated Balloon | 2020-02-10 Lutonix 035 7X80MMX40CM |
| 00801741187643 - LUTONIX® Drug Coated Balloon | 2020-02-10 Lutonix 035 7X100MMX40CM |
| 00801741187681 - LUTONIX® Drug Coated Balloon | 2020-02-10 Lutonix 035 12X60MMX40CM |
| 00801741187698 - LUTONIX® Drug Coated Balloon | 2020-02-10 Lutonix 035 7X80MMX75CM |
| 00801741187704 - LUTONIX® Drug Coated Balloon | 2020-02-10 Lutonix 035 7X100MMX75CM |
| 00801741187759 - LUTONIX® Drug Coated Balloon | 2020-02-10 Lutonix 035 7X80MMX100CM |
| 00801741187766 - LUTONIX® Drug Coated Balloon | 2020-02-10 Lutonix 035 7X100MMX100CM |
Trademark Results [Lutonix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LUTONIX 87096328 not registered Live/Pending |
C. R. BARD, INC. 2016-07-07 |
 LUTONIX 85624080 not registered Dead/Abandoned |
C. R. BARD, INC. 2012-05-14 |
 LUTONIX 77201067 3928832 Live/Registered |
Lutonix, Inc. 2007-06-08 |
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