XPS®

GUDID 00643169360846

HANDPIECE 1897200 MAGNUM II EN ROHS

MEDTRONIC XOMED, INC.

Multi-purpose surgical power tool system, line-powered

• Primary Device ID: 00643169360846
• NIH Device Record Key: 56876ab5-3dd9-4c0e-9ad7-46c2c44f5245
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XPS®
• Version Model Number: 1897200
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169360846 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002224

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

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

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169360846]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-04-29

On-Brand Devices [XPS®]

• 00613994598301: MICRODEBRIDER 1898200TRF IGS M4 REFURB
• 00643169882836: MICRODEBRIDER 1898200TLO LOANER M4 IGS
• 00643169882799: MICRODEBRIDER 1898200TRF IGS M4 REFURB
• 00643169882706: MICRODEBRIDER 1898200T IGS M4 ROHS
• 00643169553019: MICRODEBRIDER 1898200TLO LOANER M4 IGS
• 00643169360846: HANDPIECE 1897200 MAGNUM II EN ROHS
• 00643169350663: CONSOLE 1894440 MICRO MICRODEBRIDER ROHS
• 00681490048941: FOOTSWITCH 1895410 XPS SINGLE FUNCTION
• 00681490048880: FOOTSWITCH 1895400 XPS