Impla Clean- Number 3

Basic Information

• Brand Name: Impla Clean- Number 3
• Primary DI: 00014081552235
• Version / Model: 355223
• Company Name: HAGER WORLDWIDE, INC.
• Labeler DUNS: 009277971
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-14
• Public Version: 2
• Public Version Date: 2023-09-08
• Public Version Status: Update
• Public Device Record Key: 02670965-5129-4e53-8a29-5a8c19bc5f06
• Distribution End Date: 2023-08-01

Device Description

Implant Cleaning Instrument

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
EIY	INSTRUMENT, FILLING, PLASTIC, DENTAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35320	Manual dental scaler, reusable	A hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00014081552235	GS1

Customer Contacts

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