AccessGUDID - DEVICE: LP Low Profile (00190746163364)

GUDID

Device Identifier (DI) Information

Brand Name: LP Low Profile
Version or Model: 958-1045CAU
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 958-1045CAU
Company Name: AMERICAN ORTHODONTICS CORPORATION

Primary DI Number: 00190746163364
Issuing Agency: GS1
Commercial Distribution End Date: September 28, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 044668515 *Terms of Use

Device Description: DB TUBE LP UL 1ST MOL 022 NON-CONV T-14 R5D 4.5MM W/HK GP

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?
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: 199353dd-72ff-4254-bb05-a25fa578f779
Public Version Date: September 30, 2024
Public Version Number: 3
DI Record Publish Date: October 12, 2020