MINNE TIES MT-1002

GUDID 00860000906029

Maxilla-Mandibular Fixation (MMF) Suture System

KEYSTONE MANUFACTURING, LLC

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: 00860000906029
• NIH Device Record Key: 1181f4e1-e0b1-4803-823c-30398c6dcb27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MINNE TIES MT-1002
• Version Model Number: MT-1002
• 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	00860000906029 [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: 2021-08-25 Maxilla-Mandibular Fixation (MMF) Suture System
• 00860000906029 - MINNE TIES MT-1002: 2021-08-25Maxilla-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