AccessGUDID - DEVICE: Perio-Control Tips (04560264562356)

GUDID

Device Identifier (DI) Information

Brand Name: Perio-Control Tips
Version or Model: Perio-Control Tips Air Scaler Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NAKANISHI INC.

Primary DI Number: 04560264562356
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690710546 *Terms of Use

Device Description: No description.

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?
44910	Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable	A removable endpiece intended to be attached to a pneumatic dental scaling/debridement system handpiece for the application of sonic vibrational energy (e.g., at a frequency of 6 kHz) to fragment and dislodge accretions or substances [e.g., dentine, enamel, plaque, calculus] from tooth and implant surfaces during dental cleaning/periodontal procedures (e.g., stripping, finishing); it is not intended for endodontic use. It is available in a variety of designs and may also be used for the removal of orthodontic cement. 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 [?]
K991021	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f5dfe078-47e5-46ac-8390-738de5b03177
Public Version Date: February 24, 2020
Public Version Number: 5
DI Record Publish Date: September 16, 2016