AccessGUDID - DEVICE: Clean Machine™ (M595D60030KCR0)

GUDID

Device Identifier (DI) Information

Brand Name: Clean Machine™
Version or Model: D60030KCR
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: D60030KCR
Company Name: PARKELL, INC.

Primary DI Number: M595D60030KCR0
Issuing Agency: HIBCC
Commercial Distribution End Date: September 28, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 009900424 *Terms of Use

Device Description: Certified Refurbish 30khz Parkell Clean Machine™ 110 Volt Ultrasonic Tooth Scaler

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?
36047	Ultrasonic dental scaling/debridement system	An assembly of mains electricity (AC-powered) devices intended to apply ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. The system typically consists of a generator with controls (e.g., foot-switch) that produces and controls high frequency electric current, and may provide fluid irrigation; a handpiece used to convert the energy to ultrasonic oscillations; and a tip(s) intended to apply the oscillations to the procedure site; tip selection typically affects the intended application (endodontic vs periodontal).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELC	Scaler, Ultrasonic

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: f4ada8d5-f2b0-45e8-b209-a54f754a0f34
Public Version Date: October 11, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016