AccessGUDID - DEVICE: OrthoGap Archwire Markers (05060772890013)

GUDID

Device Identifier (DI) Information

Brand Name: OrthoGap Archwire Markers
Version or Model: AX-WOMOG
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AX-WOMOG
Company Name: PHOENIX ORTHODONTICS INC

Primary DI Number: 05060772890013
Issuing Agency: GS1
Commercial Distribution End Date: June 26, 2023
Device Count: 100
Labeler D-U-N-S® Number*: 002092976 *Terms of Use

Device Description: ORTHOGAP ARCHWIRE MARKERS PK100

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?
41397	Orthodontic archwire	A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. 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
DZN	INSTRUMENTS, DENTAL HAND

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: 3581ca3e-5de0-491a-a344-25f45c688aa0
Public Version Date: August 19, 2024
Public Version Number: 3
DI Record Publish Date: August 17, 2020