AccessGUDID - DEVICE: N/A (D80703622421)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 03-622-42
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 03-622-42
Company Name: DENTSPLY SIRONA ORTHODONTICS INC.

Primary DI Number: D80703622421
Issuing Agency: HIBCC
Commercial Distribution End Date: January 15, 2021
Device Count: 10
Labeler D-U-N-S® Number*: 116903307 *Terms of Use

Device Description: SS MULTI STD 16X22 LWR

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?
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: 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: b0f54b3e-034e-4f68-8da3-9c0f634b0bfe
Public Version Date: January 15, 2021
Public Version Number: 3
DI Record Publish Date: September 24, 2020