AccessGUDID - DEVICE: The Orthodontic Store (00843471144343)

GUDID

Device Identifier (DI) Information

Brand Name: The Orthodontic Store
Version or Model: 545-920
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 545-920
Company Name: Young Innovations, Inc.

Primary DI Number: 00843471144343
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: Elastic Power Chain, Continuous, 15 Inch, Emerald

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?
62073	Orthodontic inter-bracket elastic chain	A non-sterile device intended to be used during orthodontic treatment to function as an archwire/bracket ligature on several adjacent teeth and/or to exert a continuous light force to close the spaces between the teeth. It is also known as a power chain and is in the form of a series of connected loops made of an elastomeric material (e.g., polyurethane, rubber). This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ECI	BAND, ELASTIC, 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: e42c2f2c-a66c-4013-83c4-3fd9cede5534
Public Version Date: April 16, 2024
Public Version Number: 3
DI Record Publish Date: November 02, 2022