INTERSTIM®

GUDID 00643169467323

PNE KIT 3065USC ISTIM ULTRASOUND EMAN

MEDTRONIC, INC.

Sacral plexus percutaneous incontinence-control electrical stimulation system electrode

• Primary Device ID: 00643169467323
• NIH Device Record Key: 1b0d438f-918e-4189-a260-b737a02c1756
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTERSTIM®
• Version Model Number: 3065USC
• 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: 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

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169467323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080025

FDA Product Code

• EZW: Stimulator, electrical, implantable, for incontinence

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-19

On-Brand Devices [INTERSTIM®]

• 00613994925947: LEAD 305901 PNE TEST STIM LEAD EMAN
• 00613994913654: INS 3058 INTERSTIM II eMANUAL US
• 00613994756558: INS 3023 INTERSTIM eMANUAL US
• 00613994752444: LEAD 3889-41 TINED QUAD SNS EMANUAL US
• 00613994752437: LEAD 3889-33 TINED QUAD SNS EMANUAL US
• 00613994752420: LEAD 3889-28 TINED QUAD SNS EMANUAL US
• 00613994752413: LEAD 3093-41 TINED EXT ELECT SNS EMAN US
• 00613994752406: LEAD 3093-33 TINED EXT ELECT SNS EMAN US
• 00613994752390: LEAD 3093-28 TINED EXT ELECT SNS EMAN US
• 00613994601933: LEAD 3093-33 TINED QUAD EXT ELECT SNS US
• 00613994287731: Neurostimulator 3023 US InterStim
• 00613994287724: Neurostimulator 3058 US InterStim 2
• 00613994164049: CABLE 041827 INTERSTIM 1L
• 00643169103214: CABLE 357501 MINI HOOK GLOBAL
• 00643169089471: ACC 3065USC INTERSTIM PNE KIT US
• 00643169036048: CABLE 357664 TWIST LOCK GLOBAL
• 00643169036031: CABLE 357625 ISTM TEST TWIST LOCK GLOBAL
• 00643169021457: LEAD 309101 PNE TEST STIM KIT EMAN US
• 00643169021440: LEAD 309101 PNE TEST STIM KIT PAPER LIT
• 00643169013438: EXT 3095-51 QD INLINE 51CM BWL MRI-HC US
• 00643169013421: EXT 3095-25 QD INLINE 25CM BWL MRI-HC US
• 00643169013414: EXT 3095-10 QD INLINE 10CM BWL MRI-HC US
• 00643169929005: CABLE 357664 ISTM TEST TWIST LOCK GLOBAL
• 00643169928992: CABLE 357625 ISTM TEST TWIST LOCK GLOBAL
• 00643169887947: LEAD 3889-41 ISTM QUAD SNS 41CM EMAN FWU
• 00643169887930: LEAD 3889-33 ISTM QUAD SNS 33CM EMAN FWU
• 00643169887923: LEAD 3889-28 ISTM QUAD SNS 28CM EMAN FWU
• 00643169864450: LEAD 3889-41 ISTIM QUAD SNS 41CM US EMAN
• 00643169864443: LEAD 3889-33 ISTIM QUAD SNS 33CM US EMAN
• 00643169864436: LEAD 3889-28 ISTIM QUAD SNS 28CM US EMAN
• 00643169781863: LEAD 305901 PNE TST STIM FLXMED EMAN COO
• 00643169721180: CABLE 357501 MINI HOOK GLOBAL
• 00643169721173: LEAD 309101 PNE TEST STIM KIT EMAN US
• 00643169721166: LEAD 305901 PNE TEST STIM LEAD EMAN
• 00643169651135: LEAD 3889-41 ISTIM EMANUAL NO SCREENCBL
• 00643169651128: LEAD 3889-33 ISTIM EMANUAL NO SCREENCBL
• 00643169651111: LEAD 3889-28 ISTIM EMANUAL NO SCREENCBL
• 00643169467330: LEAD 3057-1SC TEST ISTIM ULTRASOUND EMAN
• 00643169467323: PNE KIT 3065USC ISTIM ULTRASOUND EMAN
• 00643169346277: EXT 3095-51 QD INLNE 51CM BWL MRI-HC EMN
• 00643169346260: EXT 3095-25 QD INLNE 25CM BWL MRI-HC EMN
• 00643169346253: EXT 3095-10 QD INLNE 10CM BWL MRI-HC EMN
• 20763000060286: CABLE 041831 PAT SCREEN INTERSTIM US
• 20643169721238: CABLE 367675 ISTM TST W/GP 6PK FM OTAY
• 20643169721221: CABLE 367637 ISTM TST W/GP 6PK FM OTAY
• 20643169721214: CABLE 357975 ISTM TEST NO GP 6PK FM OTAY
• 20643169721207: CABLE 357937 ISTM TEST NO GP 6PK FM OTAY
• 20643169721191: CABLE 357506 MINI HOOK 6PK GLOBAL
• 20643169721153: NEEDLE 041829 5 INCH GLOBAL FLEX
• 20643169721146: NEEDLE 041828 ISTM 3.5IN 6PK GLOBAL