AccessGUDID - DEVICE: 3M™ Unitek™ (00652221071194)

GUDID

Device Identifier (DI) Information

Brand Name: 3M™ Unitek™
Version or Model: 340-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 340-002
Company Name: 3M UNITEK CORPORATION

Primary DI Number: 00652221071194
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 008256356 *Terms of Use

Device Description: 3M™ Unitek™ MIA Mobile Intraoral Arch Quad Helix, 340-002, U, Curved, Size 2, 5/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?
35310	Orthodontic retainer	An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.	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: b83fc0ac-4f9e-42c9-b2b7-dd39fa3f49b8
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022