AccessGUDID - DEVICE: The Orthodontic Store (00840326406335)

GUDID

Device Identifier (DI) Information

Brand Name: The Orthodontic Store
Version or Model: 650-500-B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 650-500-B
Company Name: Young Innovations, Inc.

Primary DI Number: 00840326406335
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004193103 *Terms of Use

Device Description: Nylon Headgear Case, Blue

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?
31757	Orthodontic extraoral headgear	A dental device used in conjunction with orthodontic appliances to exert pressure on the teeth or the jaws from outside the mouth. An orthodontic headgear will typically have a strap that wraps around the patient's neck or head and an inner bow portion that is fastened to the orthodontic appliance in the patient's mouth, or utilizes rests on the chin and forehead (reverse pull headgear).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZB	Headgear, extraoral, orthodontic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K961754	000

Device Exempt from Premarket Submission: No 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: f310f36f-4e62-43b5-9cc5-36b2f5ba10d3
Public Version Date: November 10, 2022
Public Version Number: 1
DI Record Publish Date: November 02, 2022