AccessGUDID - DEVICE: AeroPro Cordless Prophy System (D691550005200)

GUDID

Device Identifier (DI) Information

Brand Name: AeroPro Cordless Prophy System
Version or Model: AP-18-PDPC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5500520
Company Name: PREMIER DENTAL PRODUCTS COMPANY

Primary DI Number: D691550005200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 014789663 *Terms of Use

Device Description: AeroPro Sterilizable Outer Sheath

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?
63498	Dental power tool system handpiece, battery-powered	A hand-held, electrically-powered dental device that includes a chuck or collet for attaching a rotary dental endpiece (e.g., polishing brush) intended to be used in dental procedures, typically for cleaning and polishing teeth. It is a battery-powered cordless instrument with an integral electric motor and push buttons for controlling the device settings; the endpiece(s) is not included. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EKX	Handpiece, Direct Drive, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180682	000

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
Storage Environment Temperature: between -10 and 50 Degrees Celsius
Storage Environment Humidity: between 45 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 515ec70d-b826-46d3-add4-77818b9df2f3
Public Version Date: March 18, 2020
Public Version Number: 1
DI Record Publish Date: March 10, 2020