XPS® Straightshot®

GUDID 00643169350687

MICRODEBRIDER 1898200T IGS M4 ROHS

MEDTRONIC XOMED, INC.

Multi-purpose surgical power tool system, line-powered

• Primary Device ID: 00643169350687
• NIH Device Record Key: b4fd25fc-d13d-4460-8c1b-a3bb716a987b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XPS® Straightshot®
• Version Model Number: 1898200T
• 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	00643169350687 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041413

FDA Product Code

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

Sterilization

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

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00643169350687]

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: 2016-04-07

On-Brand Devices [XPS® Straightshot®]

• 00643169350687: MICRODEBRIDER 1898200T IGS M4 ROHS
• 00681490693950: HANDPIECE 1897201 STRAIGHTSHOT III
• 00885074080932: MICRODEBRIDER 1898200T IGS M4