Sontec 5d Arculate Marker

Sontec 5D Arculate Marker With Alignment Notches Round Handle Titanium

Registry build 21.09.26
3manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (2), Hubei (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HMQ
Manufacturer City Province Registered as Device types
Malosa Medical Instruments (Changshu) Limited Changshu Jiangsu Contract manufacturer 24
Hubei Lanbin Medical Group Co., Ltd. Xiaogan Hubei Contract manufacturer 33
Sihong Ophsurin Co., Ltd. Suqian Jiangsu Manufacturer 17

Record

Regulatory record for Sontec 5D Arculate Marker
Listed by Sontec Instruments, Inc., United States
FDA product code HMQ
Device type Marker, Sclera
Device class Class 1
Regulation 21 CFR 886.4570
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2019-05-09

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization, Dry Heat Sterilization
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number
Sizes Length 4 in

Catalogue Numbers

Catalogue numbers for Sontec 5D Arculate Marker
Catalogue number Size Status
T12-8502 Length 4 in In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Stephens Instruments Krishna Imports Inc 61
MSI Precision Specialty Instruments MED Saver, Inc. 31
Malosa Medical Beaver-Visitec International, Ltd 2
Braunstein Marker Blink Medical Ltd 1
Marker Double Ended 3.5mm-4mm Blink Medical Ltd 1
Thornton TWO RAY Meridian Marker Sontec Instruments, Inc. 1
Bausch + Lomb Bausch & Lomb Incorporated 1
Dual Tip Marker Pen – Methylene Blue Hurricane Medical 1
Thornton Corneal Marker Sontec Instruments, Inc. 1
Scleral Marker Katena Products, Inc. 1
Marker Pad – Methylene Blue Hurricane Medical 1
Dual Tip Marker Pen – Gentian Violet Hurricane Medical 1

Showing 12 of 16. All products under Marker, Sclera

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