FDA.reportPublic FDA data

Minne Ties Agile MMF

Primary DI
00850043178002
Brand
Minne Ties Agile MMF
Company
Invisian Medical, LLC
Model
MT-1000
Catalog number
MT-1000
Device description
Minne Ties Kit: Ten (1.0 mm/18 ga), Two (0.7mm/21 ga) & One Cheek Retractor
Published
2022-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
00860000906005PreviousGS10
00850043178002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000906005008600009060058600009060050860000906005
00850043178002008500431780028500431780020850043178002

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

Contacts#

Phone, Email table
PhoneEmail
9132281857customerservice@minneties.com

Regulatory Flags#

DUNS number
117404743
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850043178040Minne Ties Agile MMFMT-2000MT-20002025-07-17
00850043178019Minne Ties Agile MMFMT-1001MT-10012022-07-01
00850043178026Minne Ties Agile MMFMT-1002MT-10022022-07-01

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
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
00860000906036MINNE TIES MT-1003KEYSTONE 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