Montgomery® Thyroplasty Implant MTF-06

GUDID EBESMTF060

Size: Female 6

BOSTON MEDICAL PRODUCTS, INC.

Preformed vocal cord medialization implant

• Primary Device ID: EBESMTF060
• NIH Device Record Key: e2e0dd07-0ee3-4798-826a-076fe3b558cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Montgomery® Thyroplasty Implant
• Version Model Number: MTF-06
• Catalog Number: MTF-06
• Company DUNS: 131855157
• Company Name: BOSTON MEDICAL PRODUCTS, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBESMTF060 [Primary]
HIBCC	EBESMTF061 [Package]; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972317

FDA Product Code

• MIX: System, Vocal Cord Medialization

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-20

On-Brand Devices [Montgomery® Thyroplasty Implant]

• EBESMTM130: Size: Male 13
• EBESMTM120: Size: Male 12
• EBESMTM110: Size: Male 11
• EBESMTM100: Size: Male 10
• EBESMTM090: Size: Male 9
• EBESMTM080: Size: Male 8
• EBESMTF110: Size: Female 11
• EBESMTF100: Size: Female 10
• EBESMTF090: Size: Female 9
• EBESMTF080: Size: Female 8
• EBESMTF070: Size: Female 7
• EBESMTF060: Size: Female 6
• 34063107101862: Size: Male 13
• 34063107101855: Size: Male 12
• 34063107101848: Size: Male 11
• 34063107101831: Size: Male 10
• 34063107101824: Size: Male 9
• 34063107101817: Size: Male 8
• 34063107101800: Size: Female 11
• 34063107101794: Size: Female 10
• 34063107101787: Size: Female 9
• 34063107101770: Size: Female 8
• 34063107101763: Size: Female 7
• 34063107101756: Size: Female 6