AccessGUDID - DEVICE: Hu-Friedy (10889950075866)

GUDID

Device Identifier (DI) Information

Brand Name: Hu-Friedy
Version or Model: UM3-30EU
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: UM3-30EU
Company Name: HU-FRIEDY MFG. CO., LLC

Primary DI Number: 10889950075866
Issuing Agency: GS1
Commercial Distribution End Date: January 19, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 005085972 *Terms of Use

Device Description: Magnetostrictive Generator 3000-30k,230V

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?
44906	Ultrasonic dental scaling/debridement system generator	A mains electricity (AC-powered) unit that functions as part of an ultrasonic dental scaling/debridement system, intended to generate, and enable control of, 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. It connects to the system handpiece, and may connect to a suitable water supply, or it may contain the water or rinsing solution (e.g., chlorhexidine) source.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELC	Scaler, ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100401	000

Device Exempt from Premarket Submission: No 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
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Celsius
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: a7e96708-f7bc-4018-b31a-03621617c0f5
Public Version Date: January 20, 2022
Public Version Number: 4
DI Record Publish Date: September 21, 2016