MINNE TIES MT-1001

GUDID 00860000906012

Maxilla-Mandibular Fixation (MMF) Suture System

KEYSTONE MANUFACTURING, LLC

Temporary maxillomandibular fixation set

• Primary Device ID: 00860000906012
• NIH Device Record Key: 843b9d70-ddf5-408f-bcfe-ec792bd6d9c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MINNE TIES MT-1001
• Version Model Number: MT-1001
• Company DUNS: 013799942
• Company Name: KEYSTONE MANUFACTURING, 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000906012 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-25
• Device Publish Date: 2021-08-17

Devices Manufactured by KEYSTONE MANUFACTURING, LLC

• 00860000906005 - MINNE TIES MT-1000: 2021-08-25 Maxilla-Mandibular Fixation (MMF) Suture System
• 00860000906012 - MINNE TIES MT-1001: 2021-08-25Maxilla-Mandibular Fixation (MMF) Suture System
• 00860000906012 - MINNE TIES MT-1001: 2021-08-25 Maxilla-Mandibular Fixation (MMF) Suture System
• 00860000906029 - MINNE TIES MT-1002: 2021-08-25 Maxilla-Mandibular Fixation (MMF) Suture System
• 00860000906036 - MINNE TIES MT-1003: 2021-08-25 Maxilla-Mandibular Fixation (MMF) Suture System
• 10860003793708 - Keystone Sterile Specimen Collection Flocked Swab - 6 inch: 2021-08-25 Absorbent Tipped Applicator, Sterile
• 10860003793715 - Keystone Sterile Specimen Collection Polyester Swab - 6 inch: 2021-08-25 Sterile Specimen Collection Sterile Polyester Swab - 6 inch
• 10860003793722 - Keystone Sterile Specimen Collection Flocked Swab - 5 inch: 2021-08-25 Sterile Specimen Collection Sterile Polyester Swab - 5 inch
• 00860003793732 - Keystone VACUETTE 3ml Virus Stabilization Tube 1200 pcs: 2021-08-25 VACUETTE 3ml Virus Stabilization Tube 1200 pcs