Stephens Instruments

Braunstein Fixed Caliper, Incision Gauge, 3.5mm/4.0mm, Single Use, 10/Box

Registry build 21.09.26
8manufacturers in China registered for this device type
6catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (1), Guangdong (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 HOE
Manufacturer City Province Registered as Device types
Malosa Medical Instruments (Changshu) Limited Changshu Jiangsu Contract manufacturer 24
Providence Enterprise Limited Shenzhen Guangdong Contract manufacturer 9
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
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

Record

Regulatory record for Stephens Instruments
Listed by Krishna Imports Inc
FDA product code HOE
Device type Caliper, 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
S4-1455 In distribution
S4-1457 In distribution
S4-1456 In distribution
SSD4 1457 In distribution
S4-1458 In distribution
ST4-1455 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MR Phaco Crestpoint Management Ltd. 55
Ambler Surgical Ambler Surgical, LLC 20
Millennium Avalign Technologies, Inc. 17
Duckworth & Kent Duckworth AND Kent Limited 15
Castroviejo Caliper Sontec Instruments, Inc. 11
gSource Gsource, LLC. 10
Ophthalmic Caliper Katena Products, Inc. 10
MSI Precision Specialty Instruments MED Saver, Inc. 9
Walcott Rx Products Walcott Rx Product Inc 8
Caliper, Ophthalmic Black & Black Surgical, Inc. 8
Boss Instruments Boss Instruments, Ltd. 8
V. Mueller Steris Corporation 7

Showing 12 of 108. All products under Caliper, 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