AccessGUDID - DEVICE: Colored Chain (00190746033650)

GUDID

Device Identifier (DI) Information

Brand Name: Colored Chain
Version or Model: 854-341
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 854-341
Company Name: AMERICAN ORTHODONTICS CORPORATION

Primary DI Number: 00190746033650
Issuing Agency: GS1
Commercial Distribution End Date: July 22, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 044668515 *Terms of Use

Device Description: CHAIN PLASTIC 15' SHORT YELLOW

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):	Yes
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?
62074	Orthodontic inter-arch elastic band	A non-sterile circular band intended to be used during orthodontic treatment to exert a continuous light force to adjust bite and jaw position for correcting malocclusions (e.g., overbite, underbite). It is made of an elastomeric material (e.g., polyurethane, rubber) and is secured to hooks on orthodontic brackets across non-opposing mandibular and maxillary teeth. 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: 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
Special Storage Condition, Specify: Keep Away from Light
Storage Environment Temperature: between 2 and 38 Degrees Celsius
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d2c3c34f-07a5-4cac-a32a-ea2e486444c9
Public Version Date: July 25, 2022
Public Version Number: 4
DI Record Publish Date: May 16, 2019