NAGAHARA CHOPPER

Basic Information

• Brand Name: NAGAHARA CHOPPER
• Primary DI: 00192896013100
• Version / Model: 12-1430L
• Catalog Number: 12-1430L
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-18
• Public Version: 2
• Public Version Date: 2026-03-05
• Public Version Status: Update
• Public Device Record Key: 07c7f71c-bc0f-4d2a-ade4-d92745018ae8

Device Description

NAGAHARA CHOPPER SINGLE ENDED ANGLED LEFT

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, Dry Heat Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNA	Spud, ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46549	Eye spud/needle	A hand-held manual ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe. It is typically made of high-grade stainless steel, and designed with a fine handle in the centre of the instrument. At one end is a thin concave blade with a rounded nose (spud), and at the other end is a spearhead-shaped needle. The ophthalmologist uses these tips to remove the foreign body/object. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896013100	GS1

Customer Contacts

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