LUTONIX® Drug Coated Balloon LX181007405F
GUDID 00801741177439
LUTONIX® 018 Drug Coated Balloon PTA Catheter, 7X40MMX100CM
LUTONIX, INC.
Peripheral angioplasty balloon catheter, drug-coated| Primary Device ID | 00801741177439 |
| NIH Device Record Key | c8b1119e-0781-4a0e-b31e-85a5fc781a65 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LUTONIX® Drug Coated Balloon |
| Version Model Number | LX181007405F |
| Catalog Number | LX181007405F |
| 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
| Phone | +1(800)321-4254 |
| medical.services@crbard.com | |
| Phone | +1(800)321-4254 |
| medical.services@crbard.com |
Device Dimensions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741177439 [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 | 3 |
| Public Version Date | 2019-09-04 |
| Device Publish Date | 2019-01-11 |
On-Brand Devices [LUTONIX® Drug Coated Balloon]
| 00801741178740 | LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 7x220mm |
| 00801741178733 | LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 6x220mm |
| 00801741177729 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 7X60MMX130CM |
| 00801741177712 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 7X40MMX130CM |
| 00801741177705 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X220MMX130CM |
| 00801741177699 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X150MMX130CM |
| 00801741177682 | LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X120MMX130CM |
| 00801741177675 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X100MMX130CM |
| 00801741177668 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X80MMX130CM |
| 00801741177651 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X60MMX130CM |
| 00801741177644 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X40MMX130CM |
| 00801741177637 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X220MMX130CM |
| 00801741177620 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X150MMX130CM |
| 00801741177613 | LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X120MMX130CM |
| 00801741177606 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X100MMX130CM |
| 00801741177590 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X80MMX130CM |
| 00801741177583 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X60MMX130CM |
| 00801741177576 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X40MMX130CM |
| 00801741177569 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X220MMX130CM |
| 00801741177552 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X150MMX130CM |
| 00801741177545 | LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X120MMX130CM |
| 00801741177538 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X100MMX130CM |
| 00801741177521 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X80MMX130CM |
| 00801741177514 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X60MMX130CM |
| 00801741177507 | LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X40MMX130CM |
| 00801741177446 | LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X60MMX100CM |
| 00801741177439 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 7X40MMX100CM |
| 00801741177422 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X220MMX100CM |
| 00801741177415 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X150MMX100CM |
| 00801741177408 | LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X120MMX100CM |
| 00801741177392 | LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X100MMX100CM |
| 00801741177385 | LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X80MMX100CM |
| 00801741177378 | LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X60MMX100CM |
| 00801741177361 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X40MMX100CM |
| 00801741177354 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X220MMX100CM |
| 00801741177347 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X150MMX100CM |
| 00801741177330 | LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X120MMX100CM |
| 00801741177323 | LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X100MMX100CM |
| 00801741177316 | LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X80MMX100CM |
| 00801741177309 | LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X60MMX100CM |
| 00801741177293 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X40MMX100CM |
| 00801741177286 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X220MMX100CM |
| 00801741177279 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X150MMX100CM |
| 00801741177262 | LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X120MMX100CM |
| 00801741177255 | LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X100MMX100CM |
| 00801741177248 | LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X80MMX100CM |
| 00801741177231 | LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X60MMX100CM |
| 00801741177224 | LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X40MMX100CM |
| 00801741163470 | Lutonix 035 DCB, 7mm x 220mm x 130cm, 5F |
| 00801741163463 | Lutonix 035 DCB, 7mm x 150mm x 130cm, 5F |
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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