RadiStop™ C11177
GUDID 15414734050057
Compression Assist Device
ST. JUDE MEDICAL, INC.
Radial artery compression device| Primary Device ID | 15414734050057 |
| NIH Device Record Key | de449ba9-3dfc-4721-a7f3-272324e655ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RadiStop™ |
| Version Model Number | C11177 |
| Catalog Number | C11177 |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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(855)478-5833 |
| customerservice@sjm.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734050050 [Primary] |
| GS1 | 15414734050057 [Package] Contains: 05414734050050 Package: [10 Units] In Commercial Distribution |
FDA Product Code
| GAX | TOURNIQUET, NONPNEUMATIC |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-04-19 |
Devices Manufactured by ST. JUDE MEDICAL, INC.
| 05415067034809 - Merlin@home™ | 2024-11-21 Transmitter |
| 05414734504706 - Merlin@home™ | 2024-11-12 Wireless Broadband Kit |
| 05415067000989 - NA | 2024-10-09 AUX Out Cable |
| 05415067006028 - NA | 2024-10-09 Adapter Cable |
| 05415067049667 - EnSite™ | 2024-09-09 X EP System Catheter Connector Cable |
| 05415067049889 - Advisor™ HD Grid X, Sensor Enabled™ | 2024-09-02 High Density Mapping Catheter |
| 05415067050182 - Agilis™ NxT Steerable Introducer Dual-Reach™ | 2024-08-23 Steerable Introducer |
| 05415067049704 - EnSite™ | 2024-08-22 X EP System Software Upgrade |
Trademark Results [RadiStop]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RADISTOP 76403986 3024053 Live/Registered |
ST. JUDE MEDICAL COORDINATION CENTER BVBA 2002-05-06 |
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