Vectris™ SureScan®

GUDID 00763000006464

LEAD 977A175 VECTRIS MRICS SUBCOMPACT

MEDTRONIC, INC.

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• Primary Device ID: 00763000006464
• NIH Device Record Key: a4ea8e61-71cb-4779-b140-be69257a157e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vectris™ SureScan®
• Version Model Number: 977A175
• Company DUNS: 796986144
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter

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
• 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
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000006464 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P840001

FDA Product Code

• LGW: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-19
• Device Publish Date: 2018-06-18

On-Brand Devices [Vectris™ SureScan®]

• 00643169109421: LEAD 977A160 MRICS SUBCOMPACT
• 00643169109414: LEAD 977A175 MRICS SUBCOMPACT
• 00643169109407: LEAD 977A190 MRICS SUBCOMPACT
• 00643169109391: LEAD 977A260 MRICS COMPACT
• 00643169109384: LEAD 977A275 MRICS COMPACT
• 00643169109377: LEAD 977A290 MRICS COMPACT
• 00763000006549: LEAD 977A290 VECTRIS MRICS SUBCOMPACT
• 00763000006525: LEAD 977A275 VECTRIS MRICS SUBCOMPACT
• 00763000006501: LEAD 977A260 VECTRIS MRICS SUBCOMPACT
• 00763000006488: LEAD 977A190 VECTRIS MRICS SUBCOMPACT
• 00763000006464: LEAD 977A175 VECTRIS MRICS SUBCOMPACT
• 00763000006440: LEAD 977A160 VECTRIS MRICS SUBCOMPACT
• 00763000324292: LEAD 977A290 VECTRIS MRICS SUBCOMPACT
• 00763000324285: LEAD 977A275 VECTRIS MRICS SUBCOMPACT
• 00763000324278: LEAD 977A260 VECTRIS MRICS SUBCOMPACT
• 00763000324261: LEAD 977A190 VECTRIS MRICS SUBCOMPACT
• 00763000324254: LEAD 977A175 VECTRIS MRICS SUBCOMPACT
• 00763000324247: LEAD 977A160 VECTRIS MRICS SUBCOMPACT