Stephens Instruments

Golf Club Foreign Body Spud, Single Use, 10/Box

Registry build 21.09.26
4manufacturers in China registered for this device type
7catalogue numbers in this listing

Who Else Makes It

All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HNA
Manufacturer City Province Registered as Device types
Malosa Medical Instruments (Changshu) Limited Changshu Jiangsu Contract manufacturer 24
66 Vision Tech Co., Ltd. Suzhou Jiangsu Private-label distributor 24
Huaian Tisurg Medical Instruments Co., Ltd. Huaian Jiangsu Contract manufacturer 22
Belle Healthcare Technology Co., Ltd. Suzhou Jiangsu Manufacturer 20

Record

Regulatory record for Stephens Instruments
Listed by Krishna Imports Inc
FDA product code HNA
Device type Spud, Ophthalmic
Device class Class 1
Regulation 21 CFR 886.4350
Premarket notification Exempt
Record published 2020-09-23
Record revised 2024-08-13 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date
Storage Special storage condition: Room Temperature
Packaging Box of 10

Catalogue Numbers

Catalogue numbers for Stephens Instruments
Catalogue number Size Status
SSD2 1135 In distribution
S2-1140 In distribution
S2-1131 In distribution
S2-1155 In distribution
S2-1135 In distribution
S2-1150 In distribution
S2-1145 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Integra® Jarit® Integra LifeSciences Production Corporation 14
MSI Precision Specialty Instruments MED Saver, Inc. 13
Ambler Surgical Ambler Surgical, LLC 12
Integra® Miltex® Integra LifeSciences Production Corporation 12
Spud, Ophthalmic Geuder Aktiengesellschaft 5
Spud Katena Products, Inc. 5
Bausch + Lomb Bausch & Lomb Incorporated 3
Phaco Chopper Sontec Instruments, Inc. 3
Pilling Teleflex Medical LLC 3
Nagahara Chopper Sontec Instruments, Inc. 3
Intracapular Manipulating Wand Sontec Instruments, Inc. 3
Novo Surgical Inc. Novo Surgical, Inc. 3

Showing 12 of 59. All products under Spud, 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