Shepard

GUDID 20763000037684

VENT TUBE MV16101 10PK GROMMET 1.14 FLPL

MEDTRONIC XOMED, INC.

Tympanostomy tube

• Primary Device ID: 20763000037684
• NIH Device Record Key: c618873f-57aa-43d5-b729-5339dc7055e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shepard
• Version Model Number: MV16101
• 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	00763000037680 [Primary]
GS1	20763000037684 [Package]; Contains: 00763000037680; 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 [Shepard]

• 20613994176817: VENT TUBE 1016503 50PK GRMT WIRE 1.02 FP
• 20613994176800: VENT TUBE 1016203 50PK GRMT WIRE 1.14 FP
• 20613994176794: VENT TUBE 1016103 50PK GROMMET 1.14 FLPL
• 20613994176756: VENT TUBE MV16501 10PK GRMT WIRE 1.14 FP
• 20613994176749: VENT TUBE MV16101 10PK GROMMET 1.14 FLPL
• 20613994176718: VENT TUBE 1016102 10PK GROMT PR 1.14 FLP
• 20613994176626: VENT TUBE 1016501 5PK GROMT WIRE 1.02 FP
• 20613994176619: VENT TUBE 1016301 5PK GROMMET 1.02 FLPL
• 20613994176602: VENT TUBE 1016201 5PK GROMT WIRE 1.14 FP
• 20613994176596: VENT TUBE 1016101 5PK GROMMET 1.14 FLPL
• 20613994146278: VENT TUBE 1086601 5PK SHEP GROM 1.02
• 20643169658411: VENT TUBE 1028025 5PK SHEP W/TAIL 1.14MM
• 20643169581559: VENT TUBE 1028026 50PK SHEPARD W/TAIL
• 20643169581542: VENT TUBE 1028025 5PK SHEP W/TAIL 1.14MM
• 20681490032647: VENT TUBE 1066155 10PK PAIR SHEPARD 1.02
• 20681490032630: VENT TUBE 1066154 10PK SHEPARD PAIR 1.14
• 20681490032104: VENT TUBE 1056157 5PK SHEP GROM W/WIRE
• 20681490032081: VENT TUBE 1056155 5PK SHEP GROMMET 1.02
• 20681490032074: VENT TUBE 1056154 5PK SHEP GROMMET 1.14
• 20681490029951: VENT TUBE 1028026 50PK SHEPARD W/TAIL
• 20681490029944: VENT TUBE 1028025 5PK SHEP W/TAIL 1.14MM
• 20681490029913: VENT TUBE 1028015 5PK SHEP W/TAB 1.14MM
• 20681490029876: VENT TUBE 1028010 5PK SHEP W/TAIL 1.14MM
• 20763000037608: VENT TUBE 1016301 5PK GROMMET 1.02 FLPL
• 20763000037585: VENT TUBE 1016101 5PK GROMMET 1.14 FLPL
• 20763000039503: VENT TUBE 1056155 5PK SHEP GROMMET 1.02
• 20763000039497: VENT TUBE 1056154 5PK SHEP GROMMET 1.14
• 20763000037738: VENT TUBE 1016203 50PK GRMT WIRE 1.14 FP
• 20763000037691: VENT TUBE MV16501 10PK GRMT WIRE 1.14 FP
• 20763000037684: VENT TUBE MV16101 10PK GROMMET 1.14 FLPL
• 20763000037660: VENT TUBE 1016102 10PK GROMT PR 1.14 FLP
• 20763000037615: VENT TUBE 1016501 5PK GROMT WIRE 1.02 FP
• 20763000037592: VENT TUBE 1016201 5PK GROMT WIRE 1.14 FP
• 20763000038988: VENT TUBE 1028026 50PK SHEPARD W/TAIL
• 20763000038971: VENT TUBE 1028025 5PK SHEP W/TAIL 1.14MM
• 20763000037721: VENT TUBE 1016103 50PK GROMMET 1.14 FLPL
• 20763000281674: VENT TUBE 1016301 5PK GROMMET 1.02 FLPL
• 20763000281650: VENT TUBE 1016101 5PK GROMMET 1.14 FLPL
• 20763000281681: VENT TUBE 1016501 5PK GROMT WIRE 1.02 FP
• 20763000281667: VENT TUBE 1016201 5PK GROMT WIRE 1.14 FP