AccessGUDID - DEVICE: The Orthodontic Store (00840326403105)

GUDID

Device Identifier (DI) Information

Brand Name: The Orthodontic Store
Version or Model: 317-125
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 317-125
Company Name: Young Innovations, Inc.

Primary DI Number: 00840326403105
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004193103 *Terms of Use

Device Description: Ortho Stone (White)

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):	No
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?
65317	Circulating tumour DNA/RNA IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of circulating tumour DNA (ctDNA) and/or RNA (ctRNA) in a clinical specimen, using a nucleic acid technique (NAT). ctDNA and ctRNA are nucleic acids from cancerous cells or tumours, found in the bloodstream, and are typically used as markers to select treatment options and/or monitor the response to cancer therapy.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EHL	POINT, ABRASIVE

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: 94b09305-8287-40bb-877a-494a21249712
Public Version Date: November 10, 2022
Public Version Number: 1
DI Record Publish Date: November 02, 2022