AccessGUDID - DEVICE: Good Fit Instant Overdentures (00817610021918)

GUDID

Device Identifier (DI) Information

Brand Name: Good Fit Instant Overdentures
Version or Model: 817610021918
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GOOD FIT TECHNOLOGIES, LLC

Primary DI Number: 00817610021918
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080341158 *Terms of Use

Device Description: Good Fit Instant Overdentures - Arch - Upper - S1 - B1

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):	No
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?
11172	Preformed complete denture	A prefabricated plastic plate designed to fit over an edentulous maxillary or mandibular alveolar ridge; an entire complement of artificial teeth from one arch is added to create a full denture. It is available in several standard sizes that can be contoured to custom fit the patient's ridge.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKO	Denture Preformed (Partially Prefabricated Denture)

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: 50c1bf1d-88b0-4497-8902-01ab7b2eff4c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 10, 2017