AccessGUDID - DEVICE: Maquira (07898938244497)

GUDID

Device Identifier (DI) Information

Brand Name: Maquira
Version or Model: CONE POSITIONER AUTOCLAVABLE UNIVERSAL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80322400059
Company Name: Maquira Industria de Produtos Odontologicos S/A

Primary DI Number: 07898938244497
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 679266866 *Terms of Use

Device Description: The AUTOCLAVABLE CONE POSITIONER helps guide the angle of the dental x-ray machine in periodontal procedures, resulting in standardized, clear radiographic images.

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):	No
Over the Counter (OTC):	Yes
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?
61131	Radiological general body-part positioner	A device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGZ	Holder, Film, X-Ray

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 449234ac-02bb-4f28-987d-1a0299ec3cd0
Public Version Date: August 15, 2024
Public Version Number: 1
DI Record Publish Date: August 07, 2024