AccessGUDID - DEVICE: Sonus Stack (Insert) (00862872000331)

GUDID

Device Identifier (DI) Information

Brand Name: Sonus Stack (Insert)
Version or Model: A47030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A47030
Company Name: ENGLER ENGINEERING CORPORATION

Primary DI Number: 00862872000331
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002965168 *Terms of Use

Device Description: Sonus 18K magnetostrictive insert with threads for interchangeable tips for the Sonus V dental device

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	No
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?
44908	Ultrasonic dental scaling/debridement system handpiece tip, periodontal	An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. 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 [?]
K811396	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
Length: 4.9 Inch
Width: .29 Inch

Device Record Status

Public Device Record Key: 0a2d79b3-a9f0-405c-a9ab-3e6a32c606a9
Public Version Date: May 12, 2021
Public Version Number: 1
DI Record Publish Date: May 04, 2021