Mastel Precision Surgical Instruments, Inc.

Radial Marker 2 Rays and Levels - 10pk Replacement Bubbles

Registry build 21.09.26
7manufacturers in China registered for this device type
148catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (6), Hubei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HMR
Manufacturer City Province Registered as Device types
Malosa Medical Instruments (Changshu) Limited Changshu Jiangsu Contract manufacturer 24
Ophsurin Co., Ltd. Suqian Jiangsu Contract manufacturer 6
Hubei Lanbin Medical Group Co., Ltd. Xiaogan Hubei Contract manufacturer 33
Asol Co., Ltd. Huaian Jiangsu Manufacturer 22
Huaian Tisurg Medical Instruments Co., Ltd. Huaian Jiangsu Contract manufacturer 22
Belle Healthcare Technology Co., Ltd. Suzhou Jiangsu Manufacturer 20
Sihong Ophsurin Co., Ltd. Suqian Jiangsu Manufacturer 17

Record

Regulatory record for Mastel Precision Surgical Instruments, Inc.
Listed by Mastel Surgical Inc., United States
FDA product code HMR
Device type Marker, Ocular
Device class Class 1
Regulation 21 CFR 886.4570
Establishment Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2022-08-23
Record revised 2025-09-26 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number, serial number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Mastel Precision Surgical Instruments, Inc.
Catalogue number Size Status
25.255.1402 In distribution
20.111.0572 In distribution
25.255.1201 In distribution
26.115.0201 In distribution
20.110.0472 In distribution
20.110.0371 In distribution
21.113.3332 In distribution
20.111.0651 In distribution
20.110.1001 In distribution
25.255.1202 In distribution
20.111.0501 In distribution
25.211.1352 In distribution
20.111.0902 In distribution
25.222.1351 In distribution
25.211.1002 In distribution
20.111.0752 In distribution
20.111.0751 In distribution
26.115.0401 In distribution
20.110.0322 In distribution
20.110.0321 In distribution
20.110.0471 In distribution
21.114.6030 In distribution
20.110.0452 In distribution
20.111.0901 In distribution
20.110.0451 In distribution
25.255.1472 In distribution
20.110.0302 In distribution
22.102.2001 In distribution
20.111.0951 In distribution
20.111.0701 In distribution
20.111.0621 In distribution
22.103.3302 In distribution
25.233.0901 In distribution
20.110.0851 In distribution
26.115.1402 In distribution
25.233.1801 In distribution
20.110.0952 In distribution
26.115.1401 In distribution
20.110.0572 In distribution
20.110.0651 In distribution
20.110.0323 In distribution
20.110.0801 In distribution
25.233.1802 In distribution
20.110.0601 In distribution
26.115.0402 In distribution
25.211.0901 In distribution
20.110.0652 In distribution
22.103.3002 In distribution
20.110.0902 In distribution
20.111.0502 In distribution
20.110.0521 In distribution
25.222.1801 In distribution
25.211.1001 In distribution
25.257.1402 In distribution
25.255.1301 In distribution
20.110.0352 In distribution
25.266.1301 In distribution
25.211.1802 In distribution
25.255.1471 In distribution
20.110.0951 In distribution
25.277.0001 In distribution
25.257.1471 In distribution
20.110.0301 In distribution
20.111.0952 In distribution
20.110.0901 In distribution
25.268.1402 In distribution
20.110.1052 In distribution
20.111.0602 In distribution
20.110.0552 In distribution
21.113.3002 In distribution
20.110.0802 In distribution
20.110.0622 In distribution
23.114.6025 In distribution
25.268.1302 In distribution
25.222.1352 In distribution
25.277.0002 In distribution
25.257.1302 In distribution
20.110.0551 In distribution
20.110.0422 In distribution
25.255.1302 In distribution
26.115.1202 In distribution
20.110.0602 In distribution
20.110.0701 In distribution
20.110.0852 In distribution
25.255.1401 In distribution
20.110.0501 In distribution
21.113.4002 In distribution
26.115.1201 In distribution
25.257.1301 In distribution
20.111.0801 In distribution
25.266.1401 In distribution
20.110.0571 In distribution
25.257.1201 In distribution
20.111.0622 In distribution
20.110.0421 In distribution
22.102.9964 In distribution
26.115.0101 In distribution
25.211.1351 In distribution
25.244.0002 In distribution
26.115.0202 In distribution
20.111.0571 In distribution
25.222.0901 In distribution
25.222.0902 In distribution
20.110.1002 In distribution
23.114.6030 In distribution
25.257.1202 In distribution
21.114.6025 In distribution
20.111.0522 In distribution
20.111.0551 In distribution
20.110.0522 In distribution
25.222.1001 In distribution
25.233.0902 In distribution
20.111.0702 In distribution
25.257.1401 In distribution
20.110.0372 In distribution
25.257.1472 In distribution
20.111.0521 In distribution
25.268.1301 In distribution
25.266.1402 In distribution
25.211.1801 In distribution
20.110.0402 In distribution
20.110.0621 In distribution
20.111.0802 In distribution
20.110.0351 In distribution
20.110.0822 In distribution
22.103.3001 In distribution
20.110.1051 In distribution
20.111.0601 In distribution
26.115.0102 In distribution
21.114.6020 In distribution
23.114.6020 In distribution
22.102.2202 In distribution
20.110.0751 In distribution
25.266.1302 In distribution
20.110.0821 In distribution
25.222.1002 In distribution
20.111.1002 In distribution
20.111.0652 In distribution
20.111.0552 In distribution
25.268.1401 In distribution
25.211.0902 In distribution
25.222.1802 In distribution
20.110.0401 In distribution
25.244.0001 In distribution
20.110.0502 In distribution
20.110.0752 In distribution
20.111.1001 In distribution
22.102.2002 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ambler Surgical Ambler Surgical, LLC 196
Walcott Rx Products Walcott Rx Product Inc 188
MR Phaco Crestpoint Management Ltd. 125
MSI Precision Specialty Instruments MED Saver, Inc. 122
Millennium Avalign Technologies, Inc. 90
Marker, Ocular Katena Products, Inc. 51
Surgical Direct Surgical Direct, Inc. 40
Rumex Rumex International Co. 37
Duckworth & Kent Duckworth AND Kent Limited 33
Epsilon USA Epsilon EYE Care PVT., Ltd. 28
Bausch + Lomb Bausch & Lomb Incorporated 27
Mrk, Ocular Katena Products, Inc. 26

Showing 12 of 213. All products under Marker, Ocular

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