AccessGUDID - DEVICE: G&H ORTHODONTICS® (10190886015278)

GUDID

Device Identifier (DI) Information

Brand Name: G&H ORTHODONTICS®
Version or Model: 125K-345-22-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: G & H Wire Company, Inc.

Primary DI Number: 10190886015278
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831465641 *Terms of Use

Device Description: AGILITY® CERAMIC BRACKET SYSTEM ROTH PRESCRIPTION .022 FULL CASE HOOKS ON 3,4,5 (20 BRACKETS)

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:	Yes
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?
58937	Orthodontic bracket, ceramic	A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJM	Bracket, Ceramic, Orthodontic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132368	000

Device Exempt from Premarket Submission: No 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: 74860023-a431-4327-98ac-f64572447eab
Public Version Date: January 31, 2023
Public Version Number: 2
DI Record Publish Date: December 11, 2019