AccessGUDID - DEVICE: Eruption Appliance (00190746155079)

GUDID

Device Identifier (DI) Information

Brand Name: Eruption Appliance
Version or Model: 855-386
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 855-386
Company Name: AMERICAN ORTHODONTICS CORPORATION

Primary DI Number: 00190746155079
Issuing Agency: GS1
Commercial Distribution End Date: September 21, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 044668515 *Terms of Use

Device Description: DB BRACKET ERUPTION APPLIANCE RND FLAT PAD COIL EYELET PK/5

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?
38741	Orthodontic lock	A dental device intended to be placed on an orthodontic archwire or rod via screwing, crimping, or soldering, for orthodontic spring activation and/or to prevent the archwire from sliding within the brackets. It may be designed in various forms (e.g., Gurin lock, stop). It does not incorporate a pin or hook. 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
ECN	Clamp, Wire, 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c3449223-c30a-4f95-ab6d-bea5dd1d86ba
Public Version Date: September 22, 2021
Public Version Number: 3
DI Record Publish Date: March 16, 2020