AccessGUDID - DEVICE: Minne Ties Agile MMF (00850043178002)

GUDID

Device Identifier (DI) Information

Brand Name: Minne Ties Agile MMF
Version or Model: MT-1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MT-1000
Company Name: Invisian Medical, LLC

Primary DI Number: 00850043178002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117404743 *Terms of Use
Previous DI: 00860000906005

Device Description: Minne Ties Kit: Ten (1.0 mm/18 ga), Two (0.7mm/21 ga) & One Cheek Retractor

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYX	Lock, Wire, And Ligature, Intraoral

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162046	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b2db9fc7-1c19-4ac9-afc8-77d30a337699
Public Version Date: August 02, 2024
Public Version Number: 2
DI Record Publish Date: July 01, 2022