MINNE TIES MT-1003

Primary DI
00860000906036
Brand
MINNE TIES MT-1003
Company
KEYSTONE MANUFACTURING, LLC
Model
MT-1003
Device description
Maxilla-Mandibular Fixation (MMF) Suture System
Published
2021-08-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYXLock, Wire, And Ligature, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYXLock, Wire, And Ligature, IntraoralDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162046000MINNE TIES MMF Suture SystemSummit Medical, Inc.2017-04-11DYX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000906036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000906036008600009060368600009060360860000906036

GMDN Terms#

Term, Definition table
TermDefinition
Temporary maxillomandibular fixation setA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
013799942
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003793732Keystone VACUETTE 3ml Virus Stabilization Tube 1200 pcsKMVIAL-VAC3ML-12002021-08-17
00860003793749Keystone VACUETTE 2ml Virus Stabilization Tube 1200 pcsKMVIAL-VAC2ML-12002021-08-17
00860003793770Keystone Nasal / Respiratory Specimen Collection Kit – 100 packKMSVKIT-KM01-1002021-08-17
00860003793794Keystone Nasal / Respiratory Specimen Collection Kit – 100 packKMSVKIT-KM03-1002021-08-17
00860005748303Keystone Nasal / Respiratory Specimen Collection Kit – 100 packKMSVKIT-KM04-1002021-08-17
00860005748310Keystone Nasal / Respiratory Specimen Collection Kit – 100 packKMSVKIT-KM05-1002021-08-17
00860005748327Keystone Bartels FlexTrans Transport Medium 3mL Tube 1800pcsKMVIAL-VTM3ML-18002021-08-17
90860000906046Keystone Sterile Nasopharyngeal Tapered Swab - 6 inchKMSWAB-600T-1002021-08-17
90860000906060Keystone Sterile Nasopharyngeal Flocked Swab - 6 inchKMSWAB-600-1002021-08-17
90860000906084Keystone Sterile Nasopharyngeal Non-Tapered Swab - 6 inchKMSWAB-600P-1002021-08-17
00860003793701Keystone Sterile Specimen Collection Flocked Swab - 6 inchKMSWAB-600P1-1002021-08-17
00860003793718Keystone Sterile Specimen Collection Polyester Swab - 6 inchKMSWAB-806P-1002021-08-17
00860003793725Keystone Sterile Specimen Collection Flocked Swab - 5 inchKMSWAB-805P-1002021-08-17
00860003793756Keystone Sterile Specimen Collection Polyurethane Foam Swab - 6 inchKMSWAB-1406P-1002021-08-17
00860000906005MINNE TIES MT-1000MT-10002021-08-17
00860000906012MINNE TIES MT-1001MT-10012021-08-17
00860000906029MINNE TIES MT-1002MT-10022021-08-17
10860003793708Keystone Sterile Specimen Collection Flocked Swab - 6 inchKMSWAB-600P1-1002021-08-17
10860003793715Keystone Sterile Specimen Collection Polyester Swab - 6 inchKMSWAB-806P-1002021-08-17
10860003793722Keystone Sterile Specimen Collection Flocked Swab - 5 inchKMSWAB-805P-1002021-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850043178040Minne Ties Agile MMFInvisian Medical, LLCDYX2025-07-17
00385640085809MINNE TIESSummit Medical, Inc.DYX2025-03-06
00385640085816MINNE TIESSummit Medical, Inc.DYX2025-03-06
00850043178002Minne Ties Agile MMFInvisian Medical, LLCDYX2022-07-01
00850043178019Minne Ties Agile MMFInvisian Medical, LLCDYX2022-07-01
00850043178026Minne Ties Agile MMFInvisian Medical, LLCDYX2022-07-01
00860000906005MINNE TIES MT-1000KEYSTONE MANUFACTURING, LLCDYX2021-08-17
00860000906012MINNE TIES MT-1001KEYSTONE MANUFACTURING, LLCDYX2021-08-17
00860000906029MINNE TIES MT-1002KEYSTONE MANUFACTURING, LLCDYX2021-08-17
00385640042383MINNE TIESSummit Medical, Inc.DYX2019-02-14
00385640042406MINNE TIESSummit Medical, Inc.DYX2019-02-14
00385640042420MINNE TIESSummit Medical, Inc.DYX2019-02-14
00385640041751MINNE TIESSummit Medical, Inc.DYX2019-01-09
00385640000642MINNE TIESSummit Medical, Inc.DYX2017-05-19
00385640028165MINNE TIESSummit Medical, Inc.DYX2017-05-19
00385640028172MINNE TIESSummit Medical, Inc.DYX2017-05-19
00385640028189MINNE TIESSummit Medical, Inc.DYX2017-05-19
10381780038221Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDYX2016-12-29
M274P6700Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDYX2016-12-29
00888118063090ARCH BARKLS-Martin L.P.DYX2016-09-20
10381780038238Miltex® Padgett®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDYX2015-09-22
H834PM6700Miltex® Padgett®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDYX2015-09-22