AccessGUDID - DEVICE: The Orthodontic Store (00843471153291)

GUDID

Device Identifier (DI) Information

Brand Name: The Orthodontic Store
Version or Model: B0290
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: B0290
Company Name: Young Innovations, Inc.

Primary DI Number: 00843471153291
Issuing Agency: GS1
Commercial Distribution End Date: April 13, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 004193103 *Terms of Use

Device Description: Traditional Roth 022 U/L 3X3

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?
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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: b53ba7e0-c280-4ce4-bdee-fbb2a87db6aa
Public Version Date: April 16, 2024
Public Version Number: 3
DI Record Publish Date: November 01, 2022