NIM

GUDID 00763000112448

PROBE 8225490X 3PK INCREMENTING 1MM TIP

MEDTRONIC XOMED, INC.

Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use

• Primary Device ID: 00763000112448
• NIH Device Record Key: e27aaaba-3b5d-4207-9f6d-177af842082b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIM
• Version Model Number: 8225490X
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 3
• 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

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

Device Dimensions

• Outer Diameter: 1 Millimeter
• Outer Diameter: 1 Millimeter
• Outer Diameter: 1 Millimeter
• Outer Diameter: 1 Millimeter
• Outer Diameter: 1 Millimeter
• Outer Diameter: 1 Millimeter
• Outer Diameter: 1 Millimeter
• Outer Diameter: 1 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000112448 [Unit of Use]
GS1	20763000112442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213246

FDA Product Code

• ETN: STIMULATOR, NERVE

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: 2022-06-27
• Device Publish Date: 2022-06-17

On-Brand Devices [NIM]

• 00763000293055: MUTING PROBE 8220325 NIM ROHS
• 00763000112455: PROBE 8225825X 3PK INCREMT STD PRASS TIP
• 00763000112448: PROBE 8225490X 3PK INCREMENTING 1MM TIP
• 00763000112462: INTFC ADAPTOR NIMCAD300 NIM 3.0 INCREMT
• 00763000745837: EMG TUBE 8229308 NIM STD 8MM ROHS
• 00763000745820: EMG TUBE 8229307 NIM STD 7MM ROHS
• 00763000745813: EMG TUBE 8229306 NIM STD 6MM ROHS
• 00763000112622: PROBE NIMDTP35 ENDO 35CM 1MM BALL TIP
• 00763000882433: EMG TUBE 8229508 NIM CONT 8MM ROHS
• 00763000882426: EMG TUBE 8229507 NIM CONT 7MM ROHS
• 00763000882419: EMG TUBE 8229506 NIM CONT 6MM ROHS
• 00763000882402: EMG TUBE 8229308 NIM STD 8MM ROHS
• 00763000882396: EMG TUBE 8229307 NIM STD 7MM ROHS
• 00763000882389: EMG TUBE 8229306 NIM STD 6MM ROHS