MINNE TIES MT-1002

Basic Information

• Brand Name: MINNE TIES MT-1002
• Primary DI: 00860000906029
• Version / Model: MT-1002
• Company Name: KEYSTONE MANUFACTURING, LLC
• Labeler DUNS: 013799942
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-17
• Public Version: 1
• Public Version Date: 2021-08-25
• Public Version Status: New
• Public Device Record Key: 1181f4e1-e0b1-4803-823c-30398c6dcb27

Device Description

Maxilla-Mandibular Fixation (MMF) Suture System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYX	Lock, Wire, And Ligature, Intraoral	Dental	872.4600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48148	Temporary maxillomandibular fixation set	A collection of sterile devices designed to provide temporary maxillomandibular fixation and immobilization. It consists of flexible plastic bands which are wrapped around teeth to form the anchorage points, and interlocking elastic chains attached to the anchorage points like laces on a hiking boot. It is used for the short term fixation of minimally displaced fractures and/or splintage of post jaw dislocation in the maxillofacial area. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860000906029	GS1

Premarket Submissions

Submission Number	Supplement Number
K162046	000