Pelotte Plus Evacuation Tip

Basic Information

• Brand Name: Pelotte Plus Evacuation Tip
• Primary DI: 00014081540249
• Version / Model: 254024
• Company Name: HAGER WORLDWIDE, INC.
• Labeler DUNS: 009277971
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-10
• Public Version: 2
• Public Version Date: 2023-09-08
• Public Version Status: Update
• Public Device Record Key: dc62c031-d193-41e6-9fe7-ed289cd70ecd
• Distribution End Date: 2023-08-01

Device Description

4" plastic dental aspirator tip (green)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYN	Mouthpiece, saliva ejector	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38759	Dental suction system cannula, reusable	A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00014081540249	GS1

Customer Contacts

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