| Primary Device ID | 00643169986404 |
| NIH Device Record Key | d45294eb-1be8-41a0-8928-c144843516c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | 3550-14 |
| Company DUNS | 796986144 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Length | 9 Centimeter |
| Length | 9 Centimeter |
| Length | 9 Centimeter |
| Length | 9 Centimeter |
| Needle Gauge | 14 Gauge |
| Length | 9 Centimeter |
| Needle Gauge | 14 Gauge |
| Length | 9 Centimeter |
| Needle Gauge | 14 Gauge |
| Length | 9 Centimeter |
| Needle Gauge | 14 Gauge |
| Length | 9 Centimeter |
| Needle Gauge | 14 Gauge |
| Length | 9 Centimeter |
| Needle Gauge | 14 Gauge |
| Length | 9 Centimeter |
| Needle Gauge | 14 Gauge |
| Length | 9 Centimeter |
| Needle Gauge | 14 Gauge |
| Length | 9 Centimeter |
| Needle Gauge | 14 Gauge |
| Length | 9 Centimeter |
| Needle Gauge | 14 Gauge |
| Length | 9 Centimeter |
| Needle Gauge | 14 Gauge |
| Length | 9 Centimeter |
| Needle Gauge | 14 Gauge |
| Length | 9 Centimeter |
| Needle Gauge | 14 Gauge |
| Length | 9 Centimeter |
| Needle Gauge | 14 Gauge |
| Length | 9 Centimeter |
| Needle Gauge | 14 Gauge |
| Length | 9 Centimeter |
| Needle Gauge | 14 Gauge |
| Length | 9 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 |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169986404 [Primary] |
| LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
| QRB | Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-05-05 |
| 00613994926005 | PRGM 97745 PAIN PTM INTELLIS PAPER LIT |
| 00613994925985 | RECHRGR 97755 RTM PAIN INTELLIS PAPR LIT |
| 00613994925961 | SCREENER 97725 PAIN WIRELESS DISP |
| 00643169078574 | MONO SEALING HOOK 13-201-1 ENDO SH2.0 |
| 00643169078567 | MONO SEALER 13-121-1 DISSECTING DS3.5C |
| 00643169078550 | MONO SEALER 13-101-1 DISSECTING DS3.0 |
| 00643169078543 | MONO SEALER 12-201-1 ENDO FL. BALL FB3.0 |
| 00643169986473 | ACCY KIT 355560 SCS EXTNSION PASSER 60CM |
| 00643169986466 | ACCY KIT 355060 TUNNELING TOOL 1X8 60CM |
| 00643169986435 | ACCY KIT 3550-68 TWST LOCK SCREEN CABLE |
| 00643169986428 | ACCY KIT 3550-43 14GA NDL CURVD TIP 6IN |
| 00643169986411 | ACCY KIT 355028 NEEDLE 14GA 6IN US |
| 00643169986404 | ACCY KIT 3550-14 SCS 3.5 CURVED NEEDLE |
| 00643169986398 | ACCY KIT 3550-P4 PASSING ELEVATOR KIT |
| 00643169953710 | ACCY 3550-80 INTRSTIM 5 IN OZ WRNCH BOOT |
| 00643169953703 | ACCY 3550-67 ALLIGATOR SCREEN CABLE US |
| 00643169953697 | ACCY 3550-45 DBS 4 IN OZ TORQUE WRENCH |
| 00643169953680 | ACCY 3550-29 PLUG CLOSED BOOT US |
| 00643169953673 | ACCY 355025 BOOTS DBS US |
| 00643169953666 | ACCY 355024 BOOTS ANCHORS US |
| 00643169953642 | ACCY 3550-07 ALIGTR CLIP SCREEN CABLE US |
| 00643169953635 | ACCY 3550-02 WRENCH AND SCREWS US |
| 00643169953604 | ACCY 355538 SCS EXTENSION PASSER US |
| 00643169953598 | ACCY 355038 1X8 38CM TUNNELING TOOL |
| 00643169953581 | ACCY 3550-06 TUNNELING TOOL US |
| 00643169953574 | ACCY 3550-05 PERC EXTNSN TUNNEL TOOL |
| 00643169953567 | ACCY 3550-03 TWISTLOCK SCREENCABLE |
| 00643169936614 | ADAPTOR 74002 2X4 SCS POCKET ADAPTOR |
| 00643169936607 | ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR |
| 00643169936591 | ADAPTOR 74001 1X4 SCS POCKET ADAPTOR |
| 00643169936584 | ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR |
| 00643169859661 | MONO SEALING HOOK 13-201-1 ENDO SH2.0 |
| 00643169859654 | MONO SEALER 13-121-1 DISSECTING DS3.5C |
| 00643169859647 | MONO SEALER 13-101-1 DISSECTING DS3.0 |
| 00643169859630 | MONO SEALER 12-201-1 ENDO FL. BALL FB3.0 |
| 00643169855649 | SW APP A610 ACTIVA CLINICIAN DBS |
| 00643169842212 | FOOTSWITCH 34-109-1 RF GENERATOR SYSTEM |
| 00643169834330 | SW APP A521 GU PATIENT EVALUATION |
| 00643169834323 | SW APP A511 GU CLINICIAN EVALUATION |
| 00643169778061 | PROG 97745FA PAT THRPY MNGR FIXED ASSET |
| 00643169778054 | PROG 8880T2 CLINICIAN TELEMMOD CTM2 US |
| 00643169771048 | SW APP A820 TDD PATIENT PROG |
| 00643169771031 | SW APP A810 TDD CLINICIAN PROG |
| 00643169738065 | SW APP A902 PATIENT DATA SERVICES |
| 00643169738058 | SW APP A901 COMM MANAGER |
| 00643169738041 | SW APP A710 SCS CLINICIAN |
| 00643169571129 | ACTV PA96000 PA US |
| 00643169449107 | ACCESSORY 355025 BOOT MVD US |
| 00763000187231 | COMM HANDSET KIT TH90GFA PH CLN FXD ASST |
| 00763000058005 | COMM HANDSET KIT TH90G01 GU PROX US |