Quick-Cross™ 518-038
GUDID 20813132029382
Quick-Cross™ Support Catheter
Philips Image Guided Therapy Corporation
Vascular guide-catheter, single-use| Primary Device ID | 20813132029382 |
| NIH Device Record Key | 21481aac-6819-426c-b1bc-44cba66a46dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quick-Cross™ |
| Version Model Number | 518-038-B |
| Catalog Number | 518-038 |
| Company DUNS | 118354223 |
| Company Name | Philips Image Guided Therapy 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 | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com |
Device Dimensions
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Lumen/Inner Diameter | 0.035 Inch |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813132029388 [Primary] |
| GS1 | 20813132029382 [Package] Contains: 00813132029388 Package: Box [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K033678
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 | 2022-03-02 |
| Device Publish Date | 2022-02-22 |
On-Brand Devices [Quick-Cross™]
| 20813132029405 | Quick-Cross™ Support Catheter |
| 20813132029399 | Quick-Cross™ Support Catheter |
| 20813132029382 | Quick-Cross™ Support Catheter |
| 20813132029375 | Quick-Cross™ Support Catheter |
| 20813132029368 | Quick-Cross™ Support Catheter |
| 20813132029351 | Quick-Cross™ Support Catheter |
| 20813132029344 | Quick-Cross™ Support Catheter |
| 20813132029337 | Quick-Cross™ Support Catheter |
| 20813132029320 | 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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