Deep Tissue Handpiece Disposable Shields

Basic Information

• Brand Name: Deep Tissue Handpiece Disposable Shields
• Primary DI: 00647529002728
• Version / Model: 6400310
• Catalog Number: 6400310
• Company Name: Biolase, Inc.
• Labeler DUNS: 152165700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• 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: 7e301b31-21cc-4220-9a57-03cad263d0bc

Device Description

Disposable shields are single-use, non-sterile, clear plastic protective covers intended for and specifically designed for use with the Biolase Deep Tissue Handpiece during pain therapy procedures. The disposable shields 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	00647529002728	GS1
Unit of Use	00647529002698	GS1

Customer Contacts

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