AccessGUDID - DEVICE: Intraoral Expansion Screws (00190746075094)

GUDID

Device Identifier (DI) Information

Brand Name: Intraoral Expansion Screws
Version or Model: 855-342
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 855-342
Company Name: AMERICAN ORTHODONTICS CORPORATION

Primary DI Number: 00190746075094
Issuing Agency: GS1
Commercial Distribution End Date: April 21, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 044668515 *Terms of Use

Device Description: FIXED FUNCT EXPANSION SCREW RAPID (13MM EXPANSION)

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?
41678	Orthodontic appliance system, bonded	An assembly of custom-made and preformed devices such as metal bands, archwires, springs, screws, power arms and/or a base plate (framework), designed to be applied to the teeth to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Often referred to as dental braces, it is intended to remain in the oral cavity for the duration of the treatment, and may be periodically adjusted by an orthodontist to effect skeletal and/or dental changes. This is a single-use device.	Obsolete	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: 3148ecf9-2c6e-4de5-9ee3-67f49d63f962
Public Version Date: February 05, 2021
Public Version Number: 5
DI Record Publish Date: April 16, 2019