Minne Ties Agile MMF MT-1000

GUDID 00850043178002

Minne Ties Kit: Eight (1.0 mm/18 ga), Four (0.7mm/21 ga) & One Cheek Retractor

Invisian Medical, LLC

Temporary maxillomandibular fixation set

• Primary Device ID: 00850043178002
• NIH Device Record Key: b2db9fc7-1c19-4ac9-afc8-77d30a337699
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Minne Ties Agile MMF
• Version Model Number: MT-1000
• Catalog Number: MT-1000
• Company DUNS: 117404743
• Company Name: Invisian Medical, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850043178002 [Primary]
GS1	00860000906005 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162046

FDA Product Code

• DYX: Lock, Wire, And Ligature, Intraoral

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: 2022-07-11
• Device Publish Date: 2022-07-01

On-Brand Devices [Minne Ties Agile MMF]

• 00850043178026: Minne Ties Sterile Medium Two Pack: Two Medium Sutures of the Same Size (.7 mm/21 ga)
• 00850043178019: Minne Ties Sterile Large Two Pack: Two Large Sutures of the Same Size (1.0 mm/18 ga)
• 00850043178002: Minne Ties Kit: Eight (1.0 mm/18 ga), Four (0.7mm/21 ga) & One Cheek Retractor