AccessGUDID - DEVICE: The Ultimate F & P Kit (D6585550121)

GUDID

Device Identifier (DI) Information

Brand Name: The Ultimate F & P Kit
Version or Model: 555012
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 555012
Company Name: Gc America Inc.

Primary DI Number: D6585550121
Issuing Agency: HIBCC
Commercial Distribution End Date: August 18, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 005473608 *Terms of Use

Device Description: The Ultimate F & P refill pack, Disc shape polisher, 6 pack

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?
35170	Dental mandrel	A slender, round, metal shaft designed to be used chairside to hold (locked into place) a rotating dental device, e.g., a grinding wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing. The mandrel will be placed into a dental handpiece that will rotate at high speed. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJQ	WHEEL, POLISHING AGENT

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: 39d61508-e838-4a2f-96d9-d6e4bf9311ea
Public Version Date: August 18, 2021
Public Version Number: 3
DI Record Publish Date: February 10, 2017