AccessGUDID - DEVICE: Morales Ecotropic Protraction Face Mask (D864ECOTROPIC0)

GUDID

Device Identifier (DI) Information

Brand Name: Morales Ecotropic Protraction Face Mask
Version or Model: Ecotropic
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ortosim, S.A. de C.V.

Primary DI Number: D864ECOTROPIC0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 821322146 *Terms of Use

Device Description: The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward and stabilizing or retracting the mandible. It is also effective in closing space and correcting negative overjet.

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:	No
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?
31757	Orthodontic extraoral headgear	A dental device used in conjunction with orthodontic appliances to exert pressure on the teeth or the jaws from outside the mouth. An orthodontic headgear will typically have a strap that wraps around the patient's neck or head and an inner bow portion that is fastened to the orthodontic appliance in the patient's mouth, or utilizes rests on the chin and forehead (reverse pull headgear).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZB	Headgear, Extraoral, Orthodontic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032392	000

Device Exempt from Premarket Submission: No 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: 18af2764-fca5-4b9d-a322-dafcba1c9818
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 26, 2017