Unique Edge

15 Deg. 5 mm Restricted Depth Stab Blade & Threaded Tip

Registry build 21.09.26
12manufacturers in China registered for this device type
186catalogue 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 Unique Edge
Listed by Unique Technologies, Inc.
FDA product code HNN
Device type Knife, Ophthalmic
Device class Class 1
Regulation 21 CFR 886.4350
Premarket notification Exempt
Record published 2023-09-01

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Packaging Box of 6

Catalogue Numbers

Catalogue numbers for Unique Edge
Catalogue number Size Status
55-2724 In distribution
52-2440-G In distribution
52-2202 In distribution
58-6700 In distribution
51-2061 In distribution
52-2842 In distribution
52-4501 In distribution
52-3001 In distribution
51-2001 In distribution
54-5000 In distribution
52-1040 In distribution
55-1214 In distribution
52-1552 In distribution
52-1252 In distribution
54-1060 In distribution
52-2561-G In distribution
52-1240 In distribution
56-5261 In distribution
52-2431 In distribution
58-2010 In distribution
52-2740-G In distribution
55-1416 In distribution
58-6602 In distribution
55-1618 In distribution
52-2631 In distribution
58-2314 In distribution
52-2242 In distribution
55-2723 In distribution
52-0550 In distribution
52-2241 In distribution
58-6902 In distribution
58-6900 In distribution
51-2301 In distribution
52-3240 In distribution
52-1502 In distribution
58-2011 In distribution
52-3001-G In distribution
52-2961 In distribution
52-2552-G In distribution
58-2015 In distribution
55-2826 In distribution
52-1840 In distribution
52-2652 In distribution
52-2540-G In distribution
56-5361 In distribution
52-2752 In distribution
58-6603 In distribution
56-4061 In distribution
52-2240-G In distribution
52-2962 In distribution
54-3061 In distribution
52-2263-G In distribution
52-3042 In distribution
52-3051 In distribution
54-1010-G In distribution
52-2240 In distribution
52-3242-G In distribution
55-2524 In distribution
52-2440 In distribution
58-2012-G In distribution
52-5261 In distribution
52-2452 In distribution
55-1520 In distribution
52-3250 In distribution
52-3040-G In distribution
52-2640-G In distribution
52-3242 In distribution
55-2924 In distribution
52-3201 In distribution
58-2312 In distribution
58-2312-G In distribution
52-2652-G In distribution
58-6600 In distribution
52-1840-G In distribution
54-5062 In distribution
52-2661-G In distribution
52-3040 In distribution
52-2201 In distribution
56-3561 In distribution
52-2661 In distribution
52-2861-G In distribution
52-2848 In distribution
52-2902F In distribution
55-1720 In distribution
58-5703 In distribution
52-1640 In distribution
54-1020 In distribution
58-2012 In distribution
55-2824 In distribution
52-2040-G In distribution
52-2662 In distribution
52-2640 In distribution
52-3042-G In distribution
52-1252-G In distribution
58-3011 In distribution
52-2831 In distribution
52-1551 In distribution
52-2531 In distribution
52-2701 In distribution
52-2461 In distribution
52-2862 In distribution
52-2461-G In distribution
52-2252 In distribution
52-1463 In distribution
52-2261-G In distribution
52-2850 In distribution
52-4501-G In distribution
52-2808 In distribution
52-3002 In distribution
58-6400 In distribution
52-2263 In distribution
52-2542 In distribution
52-2261 In distribution
52-0300 In distribution
58-5700 In distribution
52-2901 In distribution
52-2201-G In distribution
52-2040 In distribution
55-2825 In distribution
58-5702 In distribution
52-1532 In distribution
52-1501-G In distribution
54-2261 In distribution
52-2851 In distribution
54-1031 In distribution
58-6903 In distribution
58-6810 In distribution
52-2540 In distribution
52-2552 In distribution
52-1852 In distribution
52-3261 In distribution
52-2762 In distribution
52-1040-G In distribution
52-2642 In distribution
52-0350 In distribution
58-2011-G In distribution
54-1012 In distribution
52-3240-G In distribution
52-2561 In distribution
52-3231 In distribution
52-3050 In distribution
55-1517 In distribution
55-2522 In distribution
55-2022 In distribution
52-2442 In distribution
54-1012-G In distribution
52-2063 In distribution
52-3261-G In distribution
51-1901 In distribution
52-2740 In distribution
52-2250 In distribution
58-2010-G In distribution
52-2848-G In distribution
52-2931 In distribution
52-2830 In distribution
54-1010 In distribution
52-2761 In distribution
54-1000 In distribution
52-0600 In distribution
51-2501 In distribution
51-2531 In distribution
52-2731 In distribution
55-1822 In distribution
52-3036 In distribution
58-2008 In distribution
52-2063-G In distribution
52-2801 In distribution
52-2840 In distribution
52-1563 In distribution
52-2850-G In distribution
54-1013 In distribution
52-2450 In distribution
52-2761-G In distribution
52-1531 In distribution
52-1863 In distribution
52-3262 In distribution
52-2750 In distribution
52-3561 In distribution
52-2961-G In distribution
52-2861 In distribution
58-2014 In distribution
51-2361 In distribution
52-2742 In distribution
52-1501 In distribution
58-2308 In distribution
52-1440 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
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
Micro Feather Ophthalmic Scalpel with aluminum handle Feather Safety Razor Co., Ltd. 62

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