AccessGUDID - DEVICE: Phoenix Optimal 2X (05060772890662)

GUDID

Device Identifier (DI) Information

Brand Name: Phoenix Optimal 2X
Version or Model: D-O2X210-OURBK
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: D-O2X210-OURBK
Company Name: PHOENIX ORTHODONTICS INC

Primary DI Number: 05060772890662
Issuing Agency: GS1
Commercial Distribution End Date: September 02, 2024
Device Count: 10
Labeler D-U-N-S® Number*: 002092976 *Terms of Use

Device Description: OPTIMAL 2X .022 SS BOND OFFSET U R BICUSPID HK -7T:0A PK10

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
46581	Orthodontic bracket, metal	A metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. 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
EJF	BRACKET, METAL, 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: c1c1fe14-2c31-40f4-85a8-6f4f30f2288f
Public Version Date: September 03, 2024
Public Version Number: 3
DI Record Publish Date: August 17, 2020