NIM-Neuro®

GUDID 00643169547070

MAINFRAME 8253401 NIM NEURO 3.0 EL ROHS

MEDTRONIC XOMED, INC.

Nerve-locating system, line-powered Nerve-locating system, line-powered Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system

• Primary Device ID: 00643169547070
• NIH Device Record Key: c4a4a21a-4a26-469c-8408-d5c78614effd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIM-Neuro®
• Version Model Number: 8253401
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, 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: 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169547070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083124

FDA Product Code

• GWF: STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-03

On-Brand Devices [NIM-Neuro®]

• 00613994858405: PATIENT INTFC 8253410RF NEURO 3.0 REFURB
• 00613994529077: MAINFRAME 8253402 NIM NEURO 3.0 INTL
• 00613994499653: PATIENT INTERFACE 8253410 NIM NEURO 3.0
• 00613994499646: MAINFRAME 8253401 NIM NEURO 3.0
• 00643169871038: MAINFRAME 8253401RF NIM NEURO 3.0 REFURB
• 00643169782556: MAINFRAME 8253401 NIM NEURO 3.0 EL ROHS
• 00643169782518: MAINFRAME 8253401LO NIM NEURO 3.0 LOANER
• 00643169782464: PATIENT INTFC 8253410 NIM NEURO 3.0 ROHS
• 00643169547070: MAINFRAME 8253401 NIM NEURO 3.0 EL ROHS
• 00643169531000: PATIENT INTFC 8253410LO NEURO 3.0 LOANER
• 00643169530997: MAINFRAME 8253401LO NIM NEURO 3.0 LOANER
• 00643169283299: PATIENT INTFC 8253410 NIM NEURO 3.0 ROHS
• 00643169230408: MAINFRAME 8253401 NIM NEURO 3.0 ROHS
• 00643169230378: MAINFRAME 8253402 NIMNEURO 3.0 INTL ROHS