Hayden Medical

Basic Information

• Brand Name: Hayden Medical
• Primary DI: 00840319742945
• Version / Model: 200-984
• Catalog Number: 200-984
• Company Name: Hayden Medical, Inc.
• Labeler DUNS: 618214410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-14
• Public Version: 1
• Public Version Date: 2023-03-22
• Public Version Status: New
• Public Device Record Key: 932c8342-62b0-444d-ae09-1cdb033aceb8

Device Description

Ostrom Antrum Punch (Backbiter), working length 4' (10cm), pediatric, backward cutting, right-side cutting 1.5mm bite

Device Characteristics

• Single Use: No
• 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: No
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KBS	PUNCH, ADENOID	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36199	ENT soft-tissue cutting forceps	A hand-held manual surgical instrument with a biting action intended to be used to punch/cut/excise soft-tissue during an ear/nose/throat (ENT) procedure [e.g., adenoidectomy, tonsillectomy, sinus surgery, septoplasty, and/or biopsy]. It is a metallic instrument with a distal mechanism designed to bite tissue when the handles are squeezed together; some types may be used endoscopically (e.g., through a laryngopharyngoscope), and may include an integrated fluid suction channel for improved surgical field viewing. It is not intended for cutting bone (i.e., not a rongeur). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840319742945	GS1

Customer Contacts

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