MINNE TIES

GUDID 00385640000642

SUMMIT MEDICAL, INC.

Temporary maxillomandibular fixation set

• Primary Device ID: 00385640000642
• NIH Device Record Key: 9febfb35-ef32-4558-a181-f721d90702da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MINNE TIES
• Version Model Number: MT-1000
• Company DUNS: 965484699
• Company Name: SUMMIT MEDICAL, INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385640000642 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-19

On-Brand Devices [MINNE TIES]

• 00385640041751: MT-1004
• 00385640028189: MT-1002
• 00385640028172: MT-1003
• 00385640028165: MT-1001
• 00385640000642: MT-1000
• 00385640042420: IN-6032-R
• 00385640042406: IN-6032-TF
• 00385640042383: IN-6031-NF