Quick-Cross™ 518-033
GUDID M2045180331
Quick-Cross™ Support Catheter
Spectranetics Corporation
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 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 | M2045180331 |
| NIH Device Record Key | d11b4b5d-5d80-4c77-999e-d4e648d3e7a1 |
| Commercial Distribution Discontinuation | 2019-02-06 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Quick-Cross™ |
| Version Model Number | 518-033 |
| Catalog Number | 518-033 |
| 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 | 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
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com |
Device Dimensions
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M2045180330 [Primary] |
| HIBCC | M2045180331 [Package] Contains: M2045180330 Package: Box [5 Units] Discontinued: 2019-02-06 Not in Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K033678
FDA Product Code
| DQY | Catheter, Percutaneous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
[M2045180331]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 7 |
| Public Version Date | 2020-07-23 |
| Device Publish Date | 2014-08-19 |
On-Brand Devices [Quick-Cross™]
| 00813132020712 | Quick-Cross™ Support Catheter |
| 00813132020705 | Quick-Cross™ Support Catheter |
| 00813132020699 | Quick-Cross™ Support Catheter |
| 00813132020682 | Quick-Cross™ Support Catheter |
| 00813132020675 | Quick-Cross™ Support Catheter |
| 00813132020668 | Quick-Cross™ Support Catheter |
| 00813132020651 | Quick-Cross™ Support Catheter |
| 00813132020644 | Quick-Cross™ Support Catheter |
| 00813132020637 | Quick-Cross™ Support Catheter |
| M2045180661 | Quick-Cross™ Support Catheter |
| M2045180651 | Quick-Cross™ Support Catheter |
| M2045180381 | Quick-Cross™ Support Catheter |
| M2045180371 | Quick-Cross™ Support Catheter |
| M2045180361 | Quick-Cross™ Support Catheter |
| M2045180351 | Quick-Cross™ Support Catheter |
| M2045180341 | Quick-Cross™ Support Catheter |
| M2045180331 | Quick-Cross™ Support Catheter |
| M2045180321 | Quick-Cross™ Support Catheter |
Trademark Results [Quick-Cross]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUICK-CROSS 78278418 2928706 Live/Registered |
The Spectranetics Corporation 2003-07-24 |
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