Corneal Trephine Blade

25 catalogue numbers from 12-1200, listed by Sontec Instruments, Inc., United States, under Trephine, Manual, Ophthalmic. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26
2manufacturers in China registered for this device type
25catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code HRH
Manufacturer City Province Registered as Device types
Malosa Medical Instruments (Changshu) Limited Changshu Jiangsu Contract manufacturer 24
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235

Record

Regulatory record for Corneal Trephine Blade
Listed by Sontec Instruments, Inc., United States
FDA product code HRH
Device type Trephine, Manual, Ophthalmic
Device class Class 1
Regulation 21 CFR 886.4350
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2018-09-18
Record revised 2026-03-05 (version 2)

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 2.5 to 12 mm

Catalogue Numbers

Catalogue numbers for Corneal Trephine Blade
Catalogue number Size Status
12-1200 Length 6 mm In distribution
12-1250 Length 8.7 mm In distribution
12-1263 11 Millimeter Blade In distribution
12-1205 Length 6.5 mm In distribution
12-1235 Length 8 mm In distribution
12-1265 14 Millimeter Blade In distribution
12-1262 Length 10.5 mm In distribution
12-1195 Length 2.5 mm In distribution
12-1245 Length 8.5 mm In distribution
12-1202 Length 5.5 mm In distribution
12-1260 Length 9.5 mm In distribution
12-1199 Length 4.5 mm In distribution
12-1215 Length 7 mm In distribution
12-1230 Length 7.75 mm In distribution
12-1201 Length 5 mm In distribution
12-1261 Length 10 mm In distribution
12-1220 Length 7.25 mm In distribution
12-1264 Length 12 mm In distribution
12-1255 Length 9 mm In distribution
12-1210 Length 6.75 mm In distribution
12-1197 Length 3.5 mm In distribution
12-1196 Length 3 mm In distribution
12-1225 Length 7.5 mm In distribution
12-1240 Length 8.2 mm In distribution
12-1198 Length 4 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Coronet Network Medical Products, Ltd. 203
Ambler Surgical Ambler Surgical, LLC 106
Surgistar Surgistar, Inc. 94
Corneal Trephine Katena Products, Inc. 72
MSI Precision Specialty Instruments MED Saver, Inc. 53
Bausch + Lomb Bausch & Lomb Incorporated 50
Coronet CorneaGen 44
Novo Surgical Novo Surgical, Inc. 30
Eyetec Network Medical Products, Ltd. 28
Surtex Surtex Instruments Ltd 27
Beaver Beaver-Visitec International, Ltd 26
V. Mueller Carefusion 2200, Inc. 24

Showing 12 of 98. All products under Trephine, Manual, 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