ProTekt

ProTekt Williamson Trapezoid Knife, 2.5/2.9mm, Angled, Multi-Use

Registry build 21.09.26
12manufacturers in China registered for this device type
38catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (9), Shanghai (1), Shandong (1).

Chinese manufacturers registered for FDA product code HNN
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
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
2nd Sight Medical Co., Ltd. Changzhou Jiangsu Manufacturer 1
Shaanxi Xingmao Industry Co., Ltd. Xi An Shaanxi Private-label distributor 1

Record

Regulatory record for ProTekt
Listed by Diamatrix
FDA product code HNN
Device type Knife, Ophthalmic
Device class Class 1
Regulation 21 CFR 886.4350
Premarket notification Exempt
Record published 2019-10-24
Record revised 2023-06-02 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Packaging Box of 6
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for ProTekt
Catalogue number Size Status
PG 44650MU In distribution
PG 43040MU In distribution
PG 44545SS In distribution
PG 44535SS In distribution
PG 44360SS In distribution
PG 44640SS In distribution
PG 44340MU In distribution
PG 44340SS In distribution
PG 44610MU In distribution
PG 44650SS In distribution
PG 44360MU In distribution
PG 43040SS In distribution
PG 44525MU In distribution
PG 44620SS In distribution
PG 44820SS In distribution
PG 44880MU In distribution
PG 44850MU In distribution
PG 44890MU In distribution
PG 44585SS In distribution
PG 44630MU In distribution
PG 44620MU In distribution
PG 44570SS In distribution
PG 44880SS In distribution
PG 44590MU In distribution
PG 44820MU In distribution
PG 44350SS In distribution
PG 44535MU In distribution
PG 44515SS In distribution
PG 44515MU In distribution
PG 44570MU In distribution
PG 44350MU In distribution
PG 44870MU In distribution
PG 44610SS In distribution
PG 44850SS In distribution
PG 44525SS In distribution
PG 44630SS In distribution
PG 44585MU In distribution
PG 44640MU In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ambler Surgical Ambler Surgical, LLC 283
Mani Ophthalmic Knife Mani, Inc. 234
Unique Edge Unique Technologies, Inc. 186
Sharpoint Surgical Specialties México, S. de R.L. de C.V. 162
MSI Precision Specialty Instruments MED Saver, Inc. 154
Mastel Precision Surgical Instruments, Inc. Mastel Surgical Inc. 146
Anodyne Surgical Psi/Eye-Ko, Inc. 115
Ophthalmic Knife Ovation International 81
Ophthalmic Knife Katena Products, Inc. 72
Premier Edge® Microsurgical Knives Oasis Medical, Inc. 69
Micro Feather Disposable Ophthalmic Scalpel with plastic handle Feather Safety Razor Co., Ltd. 63
ExactEtch Diamatrix 63

Showing 12 of 434. All products under Knife, 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