AccessGUDID - DEVICE: Whitening Handpiece Disposable Shields (00647529002711)

GUDID

Device Identifier (DI) Information

Brand Name: Whitening Handpiece Disposable Shields
Version or Model: 6400180
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6400180
Company Name: Biolase, Inc.

Primary DI Number: 00647529002711
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 152165700 *Terms of Use

Device Description: Disposable shields are single-use, non-sterile, clear plastic protective covers intended for and specifically designed for use with the Biolase Whitening Handpiece during tooth whitening procedures. The disposable shields fit over the head of the Handpiece and must be discarded after one-time use to avoid cross-contamination between patients.

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:	Yes
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?
61049	Instrument/equipment drape, single-use, non-sterile	A non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MMP	Cover, Barrier, Protective

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 6047e460-4116-4c10-a52d-876ba2f2a150
Public Version Date: June 12, 2023
Public Version Number: 3
DI Record Publish Date: September 25, 2018