AccessGUDID - DEVICE: Intraoral Expansion Screws (00190746074479)

GUDID

Device Identifier (DI) Information

Brand Name: Intraoral Expansion Screws
Version or Model: 855-249
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 855-249
Company Name: AMERICAN ORTHODONTICS CORPORATION

Primary DI Number: 00190746074479
Issuing Agency: GS1
Commercial Distribution End Date: October 05, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 044668515 *Terms of Use

Device Description: FIXED FUNCT EXPANSION SCREW KEY 25/PKG

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:	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?
65677	Orthodontic palate expander screw, bonded	An orthodontic device intended to be used as part of a bonded palate expander to gradually spread the maxillary arch to create space for teeth alignment. It is in the form of a threaded rod with expandable pins of various lengths; it is intended to remain in the oral cavity for the duration of treatment (fixed), and may be periodically adjusted by an orthodontist to affect skeletal and/or dental changes. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.	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: 6d8f8520-6f1c-4aae-86ae-e053733155bb
Public Version Date: October 07, 2021
Public Version Number: 4
DI Record Publish Date: April 16, 2019