Stephens Instruments

Kratz Wing Speculum, Adult, 15mm Blades, Without Bar, Single Use, 10/Box

Registry build 21.09.26
11manufacturers in China registered for this device type
61catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Shandong (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 HNC
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
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
66 Vision Tech Co., Ltd. Suzhou Jiangsu Private-label distributor 24
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
Huaian Frimen Co., Ltd. Huaian Jiangsu Manufacturer 16
Huaian Wolfram Surgical Instruments Huaian Jiangsu Manufacturer 14

Record

Regulatory record for Stephens Instruments
Listed by Krishna Imports Inc
FDA product code HNC
Device type Specula, Ophthalmic
Device class Class 1
Regulation 21 CFR 886.4350
Premarket notification Exempt
Record published 2020-09-22

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date
Storage Special storage condition: Room Temperature
Packaging Box of 10
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Stephens Instruments
Catalogue number Size Status
S1-1045 In distribution
S1-1028 In distribution
S1-1075 In distribution
S1-1120 In distribution
S1-1105 In distribution
SSD1 1016 In distribution
S1-1008 In distribution
S1-1011 In distribution
S1-1016 In distribution
S1-1022 In distribution
S1-1054 In distribution
SSD1 1015 In distribution
SSD1 1001 In distribution
S1-1065 In distribution
S1-1040 In distribution
S1-1029 In distribution
S1-1066 In distribution
S1-1014U In distribution
S1-1005H In distribution
S1-1087 In distribution
SSD1 1010 In distribution
S1-1055 In distribution
S1-1013 In distribution
S1-1014V In distribution
SSD1 1005 In distribution
SSD1 1002 In distribution
S1-1005 In distribution
S1-1018 In distribution
S1-1060 In distribution
S1-1080 In distribution
S1-1003 In distribution
SSD1 1026 In distribution
S1-1057 In distribution
S1-1067 In distribution
S1-1002 In distribution
S1-1001 In distribution
S1-1297 In distribution
S1-1014K In distribution
S1-1009 In distribution
S1-1017 In distribution
SSD1 1070 In distribution
S1-1014S In distribution
S1-1100 In distribution
S1-1027 In distribution
S1-1012 In distribution
S1-1115 In distribution
S1-1052 In distribution
S1-1006 In distribution
S1-1015 In distribution
S1-1295 In distribution
S1-1026 In distribution
S1-1056 In distribution
S1-1110 In distribution
S1-1296 In distribution
S1-1070 In distribution
S1-1020 In distribution
S1-1085 In distribution
ST1-1026 In distribution
S1-1095 In distribution
S1-1025 In distribution
S1-1010 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MSI Precision Specialty Instruments MED Saver, Inc. 214
Ambler Surgical Ambler Surgical, LLC 169
Sklar Sklar Corporation 121
Walcott Rx Products Walcott Rx Product Inc 115
Ophthalmic Speculum Aurora Surgical, LLC 93
MR Phaco Crestpoint Management Ltd. 84
Millennium Avalign Technologies, Inc. 79
Ophthalmic Speculum Katena Products, Inc. 76
Bausch + Lomb Bausch & Lomb Incorporated 55
Surtex Surtex Instruments Ltd 54
Rumex Rumex International Co. 47
Wexler Surgical, Inc. Wexler Surgical, Inc. 38

Showing 12 of 360. All products under Specula, 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