Cronus™ HP - OTW PTA BALLOON CATHETER
GUDID 00383790004350
OTW High Pressure Peripheral Balloon Catheter
NIPRO MEDICAL CORPORATION
Peripheral angioplasty balloon catheter, basic| Primary Device ID | 00383790004350 |
| NIH Device Record Key | 56ee19c1-35ba-4633-a3e6-ced764061376 |
| Commercial Distribution Discontinuation | 2020-01-29 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Cronus™ HP - OTW PTA BALLOON CATHETER |
| Version Model Number | NCH+96080 |
| Company DUNS | 797372554 |
| Company Name | NIPRO MEDICAL 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 | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1 (908) 393-7030 |
| info@nipromed.com | |
| Phone | +1 (908) 393-7030 |
| info@nipromed.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 | 00383790004350 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151141
FDA Product Code
| LIT | Catheter, angioplasty, peripheral, transluminal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-01-30 |
| Device Publish Date | 2016-09-16 |
On-Brand Devices [Cronus™ HP - OTW PTA BALLOON CATHETER]
| 00383790004350 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004343 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004336 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004329 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004312 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004305 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004299 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004282 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004275 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004268 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004251 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004244 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004237 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004220 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004213 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004206 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004190 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004183 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790004008 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003995 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003988 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003971 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003964 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003957 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003803 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003797 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003780 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003773 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003766 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003759 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003742 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003735 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003728 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003711 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003704 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003698 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003681 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003674 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003605 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003599 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003582 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003575 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003568 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003551 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003544 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003537 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003520 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003513 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003506 | OTW High Pressure Peripheral Balloon Catheter |
| 00383790003407 | OTW High Pressure Peripheral Balloon Catheter |
Trademark Results [Cronus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CRONUS 98709328 not registered Live/Pending |
Guangzhou Jiutong Jewelry Co., Ltd. 2024-08-21 |
 CRONUS 97017689 not registered Live/Pending |
BLACK DOTS MARKETING SDN. BHD. 2021-09-08 |
 CRONUS 90582091 not registered Live/Pending |
Quality Lab Accessories LLC 2021-03-16 |
 CRONUS 90582084 not registered Live/Pending |
Quality Lab Accessories LLC 2021-03-16 |
 CRONUS 88493791 not registered Live/Pending |
Vere Technology LLC 2019-06-28 |
 CRONUS 87680638 5497193 Live/Registered |
CronusBrand, LLC 2017-11-10 |
 CRONUS 87035938 5114087 Live/Registered |
Sportsgear Outdoor Products LLC 2016-05-13 |
 CRONUS 87012312 not registered Live/Pending |
Rontis Corporation SA 2016-04-25 |
 CRONUS 86142799 4654232 Live/Registered |
Tippmann Sports, LLC 2013-12-13 |
 CRONUS 85722102 4720563 Live/Registered |
9089756 CANADA, INC. 2012-09-06 |
 CRONUS 79196258 5372067 Live/Registered |
CRONUS CYBER TECHNOLOGIES LTD. 2016-04-11 |
 CRONUS 79164240 4948477 Live/Registered |
Cronus Consulting Group Pty Ltd 2014-08-21 |
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