AccessGUDID - DEVICE: Model ATOZ (08800197900549)

GUDID

Device Identifier (DI) Information

Brand Name: Model ATOZ
Version or Model: Model ATOZ-A-UNI-F08
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MK Meditech Inc.

Primary DI Number: 08800197900549
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 695009476 *Terms of Use

Device Description: DESCRIPTION The plastic duplicate is a simplified form of the real ATOZ Expander. They are used to fabricate a surgical guide to hold the real ATOZ Expander in place on the palate during the anchoring screw placement. The Model ATOZ is used for making a surgical guide for ATOZ Expander. INDICATION FOR USE The Model ATOZ is used for making a surgical guide for the ATOZ Expander. TRADE NAME Model ATOZ MODEL NUMBER Model ATOZ-A-UNI-F08

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":	No
For Single-Use:	No
Prescription Use (Rx):	No
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?
63675	Orthodontic retainer support kit	A collection of devices intended to be used to facilitate use of an orthodontic teeth retainer (positioner), including placement, removal and cleaning. It typically consists of an orthodontic appliance remover, an orthodontic retainer seater, and an orthodontic appliance cleanser. The aligner, appliance or retainer is not included. This is a single-patient, reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYJ	Retainer, Screw Expansion, Orthodontic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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: 96a6a1c4-8d7d-42ed-9750-8237d2f1c6b8
Public Version Date: January 03, 2025
Public Version Number: 1
DI Record Publish Date: December 26, 2024