MINNE TIES

GUDID 00385640000642

SUMMIT MEDICAL, INC.

Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set 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