STRAIGHTSHOT®

GUDID 20681490049140

TUBING 1895522 5PK STRAIGHTSHOT TO XPS

MEDTRONIC XOMED, INC.

Surgical irrigation tubing set, single-use

• Primary Device ID: 20681490049140
• NIH Device Record Key: 19b10a92-2358-4b67-8862-eee471e47453
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STRAIGHTSHOT®
• Version Model Number: 1895522
• 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: 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
• 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	00681490049146 [Primary]
GS1	20681490049140 [Package]; Contains: 00681490049146; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081277

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-04-17

On-Brand Devices [STRAIGHTSHOT®]

• 00643169588127: MICRODEBRIDER 1899200 M5 ROHS
• 00643169588110: MICRODEBRIDER 1899200RF M5 REFURB ROHS
• 00643169492035: MICRODEBRIDER 1899200RF M5 REFURB ROHS
• 00643169448131: MICRODEBRIDER 1899200 M5 ROHS
• 00643169448124: INSTRUMENT TRAY 1899076 M5
• 00643169448117: INSTRUMENT TRAY 1898075 M4
• 20681490049140: TUBING 1895522 5PK STRAIGHTSHOT TO XPS
• 00763000172138: INSTRUMENT TRAY 1899076 M5