AccessGUDID - DEVICE: Mini Standard Edgewise (00190746113451)

GUDID

Device Identifier (DI) Information

Brand Name: Mini Standard Edgewise
Version or Model: 380-0002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 380-0002
Company Name: AMERICAN ORTHODONTICS CORPORATION

Primary DI Number: 00190746113451
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044668515 *Terms of Use

Device Description: DB BKT MINI STANDARD EDGEWISE UPPER LAT 018 T=0 A=0 R=0

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
46581	Orthodontic bracket, metal	A metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJF	BRACKET, METAL, 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: f1bc2ceb-a180-4dcd-87a6-9547b40bfa1e
Public Version Date: June 17, 2025
Public Version Number: 4
DI Record Publish Date: June 06, 2018