Reuter Bobbin

GUDID 20763000038902

VENT TUBE 1027016 50PK REUTER BOBB SST

MEDTRONIC XOMED, INC.

Tympanostomy tube

• Primary Device ID: 20763000038902
• NIH Device Record Key: 1dbd79c9-6c48-47f3-8db3-cc95cea8b659
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reuter Bobbin
• Version Model Number: 1027016
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Dimensions

• Lumen/Inner Diameter: 1.14 Millimeter
• Lumen/Inner Diameter: 1.14 Millimeter
• Lumen/Inner Diameter: 1.14 Millimeter
• Lumen/Inner Diameter: 1.14 Millimeter
• Lumen/Inner Diameter: 1.14 Millimeter
• Lumen/Inner Diameter: 1.14 Millimeter
• Lumen/Inner Diameter: 1.14 Millimeter
• Lumen/Inner Diameter: 1.14 Millimeter
• Lumen/Inner Diameter: 1.14 Millimeter
• Lumen/Inner Diameter: 1.14 Millimeter
• Lumen/Inner Diameter: 1.14 Millimeter
• Lumen/Inner Diameter: 1.14 Millimeter
• Lumen/Inner Diameter: 1.14 Millimeter
• Lumen/Inner Diameter: 1.14 Millimeter
• Lumen/Inner Diameter: 1.14 Millimeter
• Lumen/Inner Diameter: 1.14 Millimeter
• Lumen/Inner Diameter: 1.14 Millimeter
• Lumen/Inner Diameter: 1.14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000038908 [Primary]
GS1	20763000038902 [Package]; Contains: 00763000038908; Package: PK [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151067

FDA Product Code

• ETD: TUBE, TYMPANOSTOMY

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: 2020-05-19
• Device Publish Date: 2020-05-11

On-Brand Devices [Reuter Bobbin]

• 20763000037547: VENT TUBE 1010201 5PK BOBBIN 1.14 FLPL
• 20763000039183: VENT TUBE 1040004 10PK BOBBIN PAIR 1.14
• 20763000038940: VENT TUBE 1027070 5PK REUTER BOBB TITAN
• 20763000038933: VENT TUBE 1027060 5PK REUTER W/HOLE 1.14
• 20763000038926: VENT TUBE 1027040 5PK REUTER SST W/WIRE
• 20763000038919: VENT TUBE 1027017 5PK REUTER BOBBIN SST
• 20763000038902: VENT TUBE 1027016 50PK REUTER BOBB SST
• 20763000038896: VENT TUBE 1027015 5PK REUTER W/HOLE 1.14