AccessGUDID - DEVICE: Hu-Friedy (10889950075118)

GUDID

Device Identifier (DI) Information

Brand Name: Hu-Friedy
Version or Model: M6832
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: M6832
Company Name: HU-FRIEDY MFG. CO., LLC

Primary DI Number: 10889950075118
Issuing Agency: GS1
Commercial Distribution End Date: October 20, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 005085972 *Terms of Use

Device Description: SWERV3 30k Handpiece 12 Ft

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?
44907	Ultrasonic dental scaling/debridement system handpiece	A hand-held component of an ultrasonic dental debridement system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form of a pen/pencil with attached cables. This is a reusable device.	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 902af263-84f1-45be-aa94-a082828520c3
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2016