Primary Device ID | 00763000421212 |
NIH Device Record Key | 4bbe085f-1283-4503-a133-7da7dff4c7a5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SureTune™ 4 |
Version Model Number | B36104S |
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 | false |
Device Combination Product | false |
Single Use | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000421212 [Direct Marking] |
GS1 | 00763000496432 [Primary] |
GS1 | 00763000496449 [Primary] |
GS1 | 00763000496456 [Primary] |
QQC | Brain stimulation programming planning software. |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-11-01 |
Device Publish Date | 2021-10-22 |
20199150023800 - NA | 2025-06-09 CUSTOM PACK BB11X70R1 5PK AV LOOP |
20199150023824 - NA | 2025-06-09 CUSTOM PACK BB8A44R4 4PK HBC MYO |
20199150024135 - NA | 2025-06-09 CUSTOM PACK BB11A07R2 5PK BRIDGE LINE |
00613994163523 - Duran AnCore | 2025-06-09 TOOL 7620HXL HANDLE DURAN ANCORE 14L |
00613994959546 - Open Pivot™ | 2025-06-09 ACCY 558 ACTUATOR PACKAGE AVG |
00643169402539 - MOSAIC ULTRA™ | 2025-06-09 SIZERS 7308U MOSAIC ULTRA AORTIC 26L |
00643169402591 - MOSAIC™CINCH™ | 2025-06-09 SIZERS 7308C MOSAIC CINCH AORTIC 26L |
00643169525511 - CG Future™ | 2025-06-09 SIZER SET 7638S CG FUTURE 26L |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SURETUNE 97101989 not registered Live/Pending |
Medtronic Bakken Research Center B.V. 2021-11-01 |
![]() SURETUNE 88110798 not registered Live/Pending |
Medtronic Bakken Research Center B.V. 2018-09-10 |
![]() SURETUNE 85521008 4209278 Dead/Cancelled |
Sapiens Steering Brain Stimulation B.V. 2012-01-20 |