AccessGUDID - DEVICE: Herbst Appliance (00190746075223)

GUDID

Device Identifier (DI) Information

Brand Name: Herbst Appliance
Version or Model: 855-372
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 855-372
Company Name: AMERICAN ORTHODONTICS CORPORATION

Primary DI Number: 00190746075223
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 044668515 *Terms of Use

Device Description: HERBST ADVANCERS 5MM 10/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?
65804	Orthodontic rod-based aligner	An orthodontic device which includes a rod(s) intended to be bonded to teeth to correct malocclusions (e.g., overbites); it is commonly known as Herbst appliance. The rod, also referred to as a piston or tube, is typically positioned with a metal band and/or bracket and incorporates a hinge-like mechanism to allow jaw opening/closing. 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: ff74dffd-aeda-46ca-9cba-d3d1aaeead00
Public Version Date: April 11, 2022
Public Version Number: 3
DI Record Publish Date: June 24, 2019