Primary Device ID | 05415067020864 |
NIH Device Record Key | dd85909e-b4e4-4d58-82de-dfcb9d4bd5c9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | St. Jude Medical Infinity™ |
Version Model Number | DBS System |
Catalog Number | 6373 |
Company DUNS | 149818952 |
Company Name | ST. JUDE MEDICAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
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 |
Phone | +1(855)478-5833 |
customerservice@sjm.com |
Special Storage Condition, Specify | Between 0 and 0 *Store components and their packaging where they will not come in contact with liquids of any kind. |
Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05415067020864 [Primary] |
MHY | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-29 |
05415067030351 | 8CH Flex Extn, 60 cm |
05415067030344 | 8CH Flex Extn, 50 cm |
05415067030337 | 8CH Directional Lead, 40 cm, 1.5 |
05415067030320 | 8CH Directional Lead, 40 cm, 0.5 |
05415067030313 | 8CH Directional Lead, 30 cm, 1.5 |
05415067030306 | 8CH Directional Lead, 30 cm, 0.5 |
05415067020864 | 8CH Flex Extn, 90 cm |
05415067020857 | 8CH Flex Extn, 60 cm |
05415067020703 | 8CH Directional Lead, 40 cm, 1.5 |
05415067020697 | 8CH Directional Lead, 40 cm, 1.5 |
05415067020680 | 8CH Directional Lead, 40 cm, 0.5 |
05415067020673 | 8CH Directional Lead, 40 cm, 0.5 |
05415067020666 | 8CH Directional Lead, 30 cm, 1.5 |
05415067020659 | 8CH Directional Lead, 30 cm, 1.5 |
05415067020642 | 8CH Directional Lead, 30 cm, 0.5 |
05415067020635 | 8CH Directional Lead, 30 cm, 0.5 |
05415067020307 | 8CH Flex Extn, 50 cm |