AccessGUDID - DEVICE: Archwire Marker (00190746157097)

GUDID

Device Identifier (DI) Information

Brand Name: Archwire Marker
Version or Model: 861-032892
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 861-032892
Company Name: AMERICAN ORTHODONTICS CORPORATION

Primary DI Number: 00190746157097
Issuing Agency: GS1
Commercial Distribution End Date: July 08, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 044668515 *Terms of Use

Device Description: SUPPLIES ARCHWIRE MARKER 100/PK

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?
45251	Orthodontic appliance relief material	A device used to cover the offending sharp edges of an orthodontic appliance being worn by the user in order to provide relief from the discomforts that this can cause. It can be presented as a sheet, strip, or rod and is typically made of a mouldable wax or silicone material that is easy to manipulate with the fingers in order to cover the offending protrusions of the orthodontic appliance that are causing irritations in the patient's mouth. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGD	Wax, Dental, Intraoral

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: aa84d3ee-d143-4ea9-b89d-88c1aeb8597c
Public Version Date: July 09, 2020
Public Version Number: 3
DI Record Publish Date: June 02, 2020