Summit Medical

GUDID 10385640068885

Summit Medical, Inc.

Tympanostomy tube

• Primary Device ID: 10385640068885
• NIH Device Record Key: fe7fa86d-1859-4eae-8c82-ddfaa420f5fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summit Medical
• Version Model Number: VT-0406-01
• Company DUNS: 965484699
• Company Name: Summit Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• 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: 888-229-2875
• Email: CustomerService@innoviamedical.com
• Phone: 888-229-2875
• Email: CustomerService@innoviamedical.com
• Phone: 888-229-2875
• Email: CustomerService@innoviamedical.com
• Phone: 888-229-2875
• Email: CustomerService@innoviamedical.com
• Phone: 888-229-2875
• Email: CustomerService@innoviamedical.com
• Phone: 888-229-2875
• Email: CustomerService@innoviamedical.com
• Phone: 888-229-2875
• Email: CustomerService@innoviamedical.com
• Phone: 888-229-2875
• Email: CustomerService@innoviamedical.com
• Phone: 888-229-2875
• Email: CustomerService@innoviamedical.com
• Phone: 888-229-2875
• Email: CustomerService@innoviamedical.com
• Phone: 888-229-2875
• Email: CustomerService@innoviamedical.com
• Phone: 888-229-2875
• Email: CustomerService@innoviamedical.com
• Phone: 888-229-2875
• Email: CustomerService@innoviamedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385640068888 [Primary]
GS1	10385640068885 [Package]; Contains: 00385640068888; Package: SHELF BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830228

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: 2022-10-14
• Device Publish Date: 2022-10-06

On-Brand Devices [Summit Medical]

• 00385640048774: 3-C-T60-4H-4X25
• 00385640048767: 3-C-GAN-18X15
• 00385640048750: 3-C-MH-12X35
• 00385640048804: 3-C-T60-BB-4X25
• 00385640048798: 3-C-1H1-12X10
• 00385640049313: 3-C-T60-1HV-3X15
• 00385640049344: 3-C-MAN-12X10
• 00385640049337: 3-C-T60-1H2-4X15
• 00385640049320: 3-C-VDS-12X23
• 00385640049412: 3-C-1H2-12X10
• 00385640049405: 3-C-1H2-17X8
• 00385640049399: 3-C-T60-1H2-4X25
• 00385640049498: 3-C-T60-1H1-3X23
• 00385640049474: 3-H-BA-MC-6X45
• 00385640049467: 3-H-BA-MC-5X45
• 00385640049528: 3-C-VDS-3X30
• 00385640049511: 3-C-4H-2X15
• 00385640049573: 3-C-MC-4X15
• 00385640049566: 3-C-24H-2X15
• 00385640049559: 3-C-T60-BB-4X15
• 00385640049689: 3-C-INFU8-14X15
• 00385640049672: 3-C-INFU8-12X30
• 00385640049665: 3-C-INFU8-12X26
• 00385640049863: 3-C-T60-LV-3X27
• 00385640049856: 3-C-MC-14X15
• 00385640049849: 3-H-BA-TP-3X25
• 00385640050050: 3-C-T60-1H1-2X10
• 00385640050043: 3-C-1H1-18X7
• 00385640050074: 3-C-T60-1H1-3X20
• 00385640050067: 3-H-BA-VDS-12X23
• 00385640050081: 3-C-1H1-16X7
• 00385640050340: 3-C-MH-2X16
• 00385640050333: 3-C-MH-3X12
• 00385640050609: 3-C-TP-12X10
• 00385640050593: 3-C-1H2-18X16
• 00385640050586: 3-C-1H3-18X16
• 00385640050623: 3-C-4H-3X12
• 00385640050616: 3-H-BA-BB-2X25
• 00385640050814: 3-C-1H2-11X15
• 00385640050807: 3-C-1H2-11X27
• 00385640050791: 3-C-T60-1H1-5X34
• 00385640050784: 3-H-BA-BB-10X23
• 00385640050777: 3-C-INFU8-16X25
• 00385640050760: 3-C-1HV-18X9
• 00385640050753: 3-C-GAN-12X22
• 00385640050920: 3-H-BA-SP-4X16
• 00385640050913: 3-H-BA-LV-4X16
• 00385640050906: 3-H-BA-LV-4X32
• 00385640050890: 3-H-BA-LV-4X26
• 00385640050883: 3-H-BA-CA-4X26