Whitening Handpiece Disposable Shields

Basic Information

• Brand Name: Whitening Handpiece Disposable Shields
• Primary DI: 00647529002711
• Version / Model: 6400180
• Catalog Number: 6400180
• Company Name: Biolase, Inc.
• Labeler DUNS: 152165700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2018-09-25
• Public Version: 3
• Public Version Date: 2023-06-12
• Public Version Status: Update
• Public Device Record Key: 6047e460-4116-4c10-a52d-876ba2f2a150

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MMP	Cover, Barrier, Protective	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00647529002711	GS1
Unit of Use	00647529002704	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]