AccessGUDID - DEVICE: The Orthodontic Store (00840326412343)

GUDID

Device Identifier (DI) Information

Brand Name: The Orthodontic Store
Version or Model: ECCM12
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ECCM12
Company Name: Young Innovations, Inc.

Primary DI Number: 00840326412343
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: Niti Closed Coil Spring 12Mm Med

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?
31797	Orthodontic spring	A dental device in the shape of a coil intended to be placed around an archwire, a rod, in a bracket, on hooks, pins, and/or between teeth, to apply force (e.g., rotational, uprighting, horizontal) as part of an orthodontic force-producing appliance system. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ECO	SPRING, ORTHODONTIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 1c8fe65a-3c58-472e-b43f-70a0db7fd54e
Public Version Date: April 16, 2024
Public Version Number: 3
DI Record Publish Date: November 01, 2022