Shah

GUDID 20763000038094

VENT TUBE 1018101 5PK SHAH W/WIRE 1.14ID

MEDTRONIC XOMED, INC.

Tympanostomy tube

• Primary Device ID: 20763000038094
• NIH Device Record Key: b2879f27-dd34-46cf-995f-258fc65dac18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shah
• Version Model Number: 1018101
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000038090 [Primary]
GS1	20763000038094 [Package]; Contains: 00763000038090; Package: PK [5 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: 2020-05-01
• Device Publish Date: 2020-04-23

On-Brand Devices [Shah]

• 20613994492559: VENT TUBE MV16150 10PK SHAH FLPL
• 20613994492542: VENT TUBE 1018101 5PK SHAH W/WIRE 1.14ID
• 20613994492535: VENT TUBE 1018100 5PK SHAH 1.14ID FLPL
• 20681490040888: VENT TUBE 14311 5PK MINI SHAH .76MM FLPL
• 20681490032180: VENT TUBE 1056174 5PK SHAH 1.14 FLPL
• 20763000038087: VENT TUBE 1018100 5PK SHAH 1.14ID FLPL
• 20763000039923: VENT TUBE 14311 5PK MINI SHAH .76MM FLPL
• 20763000038100: VENT TUBE MV16150 10PK SHAH FLPL
• 20763000038094: VENT TUBE 1018101 5PK SHAH W/WIRE 1.14ID
• 20763000281827: VENT TUBE 1018100 5PK SHAH 1.14ID FLPL
• 20763000282992: VENT TUBE 14311 5PK MINI SHAH .76MM FLPL
• 20763000281834: VENT TUBE 1018101 5PK SHAH W/WIRE 1.14ID