AccessGUDID - DEVICE: Shiner Magnet System (00842092112694)

GUDID

Device Identifier (DI) Information

Brand Name: Shiner Magnet System
Version or Model: 1400003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1400003
Company Name: Preat Corporation

Primary DI Number: 00842092112694
Issuing Agency: GS1
Commercial Distribution End Date: October 28, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 117776048 *Terms of Use

Device Description: Shiner Magnet Starter Kit of 4

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
38578	Magnetic dental precision attachment	A device with magnetic properties designed for fixation of a removable dental prosthesis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGG	Attachment, Precision, All

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: a038184b-1665-43eb-b299-a24b0518d67a
Public Version Date: January 11, 2024
Public Version Number: 7
DI Record Publish Date: September 16, 2016