AccessGUDID - DEVICE: Phoenix Optimal (05060772890105)

GUDID

Device Identifier (DI) Information

Brand Name: Phoenix Optimal
Version or Model: D-80010-238B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: D-80010-238B
Company Name: PHOENIX ORTHODONTICS INC

Primary DI Number: 05060772890105
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 MBT .022 BOND BUCCAL TUBE SGL CONVERT U L 6 -14T:10DO 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?
31759	Orthodontic tube	A device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. 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
DZD	TUBE, 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: fc74a2cc-c45b-4aaf-b4dd-8b53d511905f
Public Version Date: September 03, 2024
Public Version Number: 3
DI Record Publish Date: August 17, 2020