Shah

GUDID 20763000038100

VENT TUBE MV16150 10PK SHAH FLPL

MEDTRONIC XOMED, INC.

Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube

• Primary Device ID: 20763000038100
• NIH Device Record Key: 7fda95cd-e5c2-41ce-8161-ec4354a1f12b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shah
• Version Model Number: MV16150
• 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	00763000038106 [Primary]
GS1	20763000038100 [Package]; Contains: 00763000038106; Package: PK [10 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