coraCross
GUDID 00850025525046
Cora Cross Coronary Crossing Catheter 14X135cm
REFLOW MEDICAL, INC.
Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use| Primary Device ID | 00850025525046 |
| NIH Device Record Key | e4bfdff7-0c03-4718-9250-73632b5310ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | coraCross |
| Version Model Number | CRX14135US |
| Company DUNS | 962545294 |
| Company Name | REFLOW MEDICAL, 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
| Catheter Working Length | 135 Centimeter |
| Guidewire Diameter | 0.014 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850025525046 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210188
FDA Product Code
| DQY | Catheter, Percutaneous |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-11 |
| Device Publish Date | 2021-06-03 |
On-Brand Devices [coraCross]
| 00850025525053 | Cora Cross Coronary Crossing Catheter 14X150cm |
| 00850025525046 | Cora Cross Coronary Crossing Catheter 14X135cm |
Trademark Results [coraCross]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CORACROSS 98187387 not registered Live/Pending |
ReFlow Medical, Inc. 2023-09-19 |
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