AccessGUDID - DEVICE: Empower2 (00190746044908)

GUDID

Device Identifier (DI) Information

Brand Name: Empower2
Version or Model: 008-18-2618H
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 008-18-2618H
Company Name: AMERICAN ORTHODONTICS CORPORATION

Primary DI Number: 00190746044908
Issuing Agency: GS1
Commercial Distribution End Date: August 29, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 044668515 *Terms of Use

Device Description: DB TUBE SL EMPOWER MAX LEFT 1ST MOLAR 018 SLOT T-18 A=0 R10D W/HK MES

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?
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: b6f923fe-a180-4a11-acfb-a28080c57e37
Public Version Date: June 19, 2020
Public Version Number: 3
DI Record Publish Date: August 29, 2017