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 |
Phone | +1(855)478-5833 |
customerservice@sjm.com |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05414734050050 [Primary] |
GS1 | 15414734050057 [Package] Contains: 05414734050050 Package: [10 Units] In Commercial Distribution |
GAX | TOURNIQUET, NONPNEUMATIC |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-04-19 |
05415067001474 - WorkMate™ Unity™ | 2025-09-08 Module HL-7 Module |
05415067001481 - WorkMate™ Unity™ | 2025-09-08 Module DICOM Module |
05415067051226 - EnSite™ | 2025-08-25 X EP System Display Workstation |
05415067051233 - NA | 2025-08-25 ADAS 3D Base License Software License |
05415067051257 - EnSite™ | 2025-08-25 X EP System Display Workstation |
05415067051264 - NA | 2025-08-25 ADAS 3D LA License Software License |
05415067051295 - NA | 2025-08-25 ADAS 3D LV License Temporary Software License |
05415067051301 - NA | 2025-08-25 ADAS 3D LV License Software License |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() RADISTOP 76403986 3024053 Live/Registered |
ST. JUDE MEDICAL COORDINATION CENTER BVBA 2002-05-06 |