AccessGUDID - DEVICE: Beta Titanium Wire (00190746068669)

GUDID

Device Identifier (DI) Information

Brand Name: Beta Titanium Wire
Version or Model: 845-VS-16W
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 845-VS-16W
Company Name: AMERICAN ORTHODONTICS CORPORATION

Primary DI Number: 00190746068669
Issuing Agency: GS1
Commercial Distribution End Date: November 16, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 044668515 *Terms of Use

Device Description: WIRE B-TI VLP SM UNIV 016 IND 10/PK

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
16204	Orthodontic wire	A thread or slender rod of metal (e.g., stainless steel, precious metal) incorporated into an orthodontic appliance, typically as part of an orthodontic appliance system. It is available in various dimensions and grades, and is used to exert pressure on teeth in order to alter their position. 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
DZC	Wire, Orthodontic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: less than 38 Degrees Celsius
Storage Environment Humidity: between 0 and 60 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8e6a9d58-98c6-4ec4-b2a5-156ca9ad8203
Public Version Date: January 17, 2025
Public Version Number: 6
DI Record Publish Date: July 13, 2018