AccessGUDID - DEVICE: Absolute Polishers™ (10810000526014)

GUDID

Device Identifier (DI) Information

Brand Name: Absolute Polishers™
Version or Model: S081
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: S081
Company Name: PARKELL, INC.

Primary DI Number: 10810000526014
Issuing Agency: GS1
Commercial Distribution End Date: March 10, 2020
Device Count: 24
Labeler D-U-N-S® Number*: 009900424 *Terms of Use

Device Description: Absolute Polishers™; Cup Shapers (non-diamond)

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):	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?
63517	Dental abrasive point, single-use	A sterile rotary endpiece designed to be attached to a dental power tool handpiece to perform a specific rotating mechanical function during a dental or orthodontic procedure, typically for polishing and smoothing natural or restorative dental materials (e.g., to finish a crown). Also referred to as a polisher, it is available in various forms [e.g., conical] and sizes and is made of synthetic polymer materials (e.g., silicone, rubber). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJQ	Wheel, Polishing Agent
EHJ	Disk, Abrasive

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
Storage Environment Temperature: between 2 and 28 Degrees Celsius
Special Storage Condition, Specify: Store in cool, dark, dry-humidity environment

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c3d14c65-7eb5-4bd8-9c75-3a1e26d288b3
Public Version Date: December 25, 2023
Public Version Number: 5
DI Record Publish Date: August 02, 2019