ENVOY SM7459
GUDID 10886704048763
GC ENVOY 6F .070 100CM XBRCA
CORDIS CORPORATION
Vascular guide-catheter, single-use| Primary Device ID | 10886704048763 |
| NIH Device Record Key | 9c5a3127-5770-4b70-bd08-e3b70aeabd76 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENVOY |
| Version Model Number | SM7459 |
| Catalog Number | SM7459 |
| Company DUNS | 806136177 |
| Company Name | CORDIS 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to temperatures above 54 degrees C (130 F) may damage the catheter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damanged |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dark, dry place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10886704048763 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K021593
FDA Product Code
| DQY | CATHETER, PERCUTANEOUS |
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 | 2020-07-23 |
| Device Publish Date | 2016-08-01 |
On-Brand Devices [ENVOY]
| 20705032043004 | GCENVOY 5F .056 90CM BENTSONII |
| 20705032042939 | GC 6F ENVOY .070 INCHES 122CM STR |
| 20705032031315 | GC ENVOY 6F .067 100CM MPA |
| 10886704048763 | GC ENVOY 6F .070 100CM XBRCA |
| 10886704048756 | GC ENVOY 6F .070 100CM 2SH JL4 |
| 10886704048749 | GC 6F XLL ENVOY .070 100CM AL2 |
| 10886704048732 | GC ENVOY 6F .070 100CM 2SH JR4 |
| 10886704048725 | GC 6F XLL ENVOY .070 100CM JCR4 |
| 10886704048718 | GC 6F XLL ENVOY .070 100CM HS |
| 10886704048701 | GC 6F XLL ENVOY .070 100CM MPA1 |
| 10886704048695 | GC 6F XLL ENVOY .070 100CM RCB |
| 10886704048688 | GC 6F XLL ENVOY .070 100CM 3DRC |
| 10886704048671 | GC ENVOY 5F .056 110CM STR |
| 10886704048664 | GC ENVOY 5F .056 110CM SIM2 |
| 10886704048657 | GC ENVOY 6F .070 110CM MPD |
| 10886704048640 | GC ENVOY 6F .067 120CM MPD |
| 10886704048633 | GC ENVOY 6F .067 65CM C2 |
| 10886704044215 | GC ENVOY 5F .056 110CM MPD |
| 10886704044208 | GC ENVOY 6F .067 90CM SIM1 |
| 10886704044192 | GC ENVOY 5F .056 115CM SIM1 |
| 10886704044161 | GC ENVOY 6F .067 110CM STR |
| 10886704044154 | GC ENVOY 6F .067 110CM MPD |
| 10886704044147 | GC ENVOY 6F .067 115CM MPC |
Trademark Results [ENVOY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENVOY 98404031 not registered Live/Pending |
Envoy Mortgage, Ltd. 2024-02-13 |
 ENVOY 98222601 not registered Live/Pending |
American Airlines, Inc. 2023-10-13 |
 ENVOY 98177597 not registered Live/Pending |
John Middleton Co. 2023-09-13 |
 ENVOY 97474391 not registered Live/Pending |
Acadian Seaplants Limited 2022-06-24 |
 ENVOY 97343984 not registered Live/Pending |
Stone Ridge Technology 2022-04-02 |
 ENVOY 97238319 not registered Live/Pending |
Foundation Devices, Inc. 2022-01-25 |
 ENVOY 90653623 not registered Live/Pending |
Acadian Seaplants Limited 2021-04-18 |
 ENVOY 90606228 not registered Live/Pending |
Remarkable Foods, Inc. 2021-03-26 |
 ENVOY 90361221 not registered Live/Pending |
Bye Aerospace, Inc. 2020-12-05 |
 ENVOY 90319625 not registered Live/Pending |
Danatos, James C 2020-11-14 |
 ENVOY 88226471 not registered Live/Pending |
General Motors LLC 2018-12-12 |
 ENVOY 88169819 not registered Live/Pending |
Exemplis LLC 2018-10-25 |
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