Phaco Nucleus Chopper

Phaco Nucleus Chopper Ball END TIP Titanium

Registry build 21.09.26
4manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HNA
Manufacturer City Province Registered as Device types
Malosa Medical Instruments (Changshu) Limited Changshu Jiangsu Contract manufacturer 24
66 Vision Tech Co., Ltd. Suzhou Jiangsu Private-label distributor 24
Huaian Tisurg Medical Instruments Co., Ltd. Huaian Jiangsu Contract manufacturer 22
Belle Healthcare Technology Co., Ltd. Suzhou Jiangsu Manufacturer 20

Record

Regulatory record for Phaco Nucleus Chopper
Listed by Sontec Instruments, Inc., United States
FDA product code HNA
Device type Spud, Ophthalmic
Device class Class 1
Regulation 21 CFR 886.4350
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2020-02-24
Record revised 2025-10-30 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Dry Heat Sterilization, Moist Heat or Steam Sterilization
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Phaco Nucleus Chopper
Catalogue number Size Status
T12-1410 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Integra® Jarit® Integra LifeSciences Production Corporation 14
MSI Precision Specialty Instruments MED Saver, Inc. 13
Ambler Surgical Ambler Surgical, LLC 12
Integra® Miltex® Integra LifeSciences Production Corporation 12
Stephens Instruments Krishna Imports Inc 7
Spud, Ophthalmic Geuder Aktiengesellschaft 5
Spud Katena Products, Inc. 5
Bausch + Lomb Bausch & Lomb Incorporated 3
Phaco Chopper Sontec Instruments, Inc. 3
Pilling Teleflex Medical LLC 3
Nagahara Chopper Sontec Instruments, Inc. 3
Intracapular Manipulating Wand Sontec Instruments, Inc. 3

Showing 12 of 59. All products under Spud, Ophthalmic

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer