Zethon

Basic Information

• Brand Name: Zethon
• Primary DI: 05060528013529
• Version / Model: 103524
• Company Name: ZETHON LIMITED
• Labeler DUNS: 774901748
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-22
• Public Version: 1
• Public Version Date: 2025-10-30
• Public Version Status: New
• Public Device Record Key: 4dbba901-b61e-4c5e-b57f-a475c17bf5ad

Device Description

P-P02 - PERFORATOR HANDPIECE - AIR

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	874.4250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58189	Bone/joint surgical power tool motorized handpiece/set, pneumatic	A pneumatically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a non-dental surgical procedure. It includes a pneumatic motor and one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect the endpieces, and typically includes a pneumatic hose; the endpieces are not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060528013529	GS1

Premarket Submissions

Submission Number	Supplement Number
K233958	000