Primary Device ID | 00643169516786 |
NIH Device Record Key | 0bf08741-3d06-40bc-8a93-3baf9bbc384b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DBS |
Version Model Number | 3391S-40 |
Company DUNS | 796986144 |
Company Name | MEDTRONIC, INC. |
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 | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
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(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Length | 40 Centimeter |
Length | 40 Centimeter |
Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169516786 [Primary] |
OLM | Deep brain stimulator for obsessive compulsive disorder (OCD) |
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 | 2017-09-18 |
00643169516786 | LEAD 3391S-40 DBS HDE EMAN NO SCRNR CBL |
00643169516571 | LEAD 3389S-40 DBS STMLOC .5MM ACTVA EMAN |
00643169516557 | LEAD 3389S-28 DBS STMLOC .5MM ACTVA EMAN |
00643169516540 | LEAD 3387S-40 DBS STMLOC ACTIVA LBL UPDT |