Ambler Surgical

Ambler capsule polishing sweeper/curette, 5 7/8”, double-ended, for pristine cleansing of the capsule for reduced PCO, to liberate lec’s from the capsule rim and remove cortical strands,…

Registry build 21.09.26

Ambler capsule polishing sweeper/curette, 5 7/8”, double-ended, for pristine cleansing of the capsule for reduced PCO, to liberate lec’s from the capsule rim and remove cortical strands, reduce inflammation and lessen capsular fibrosis, round handle

8manufacturers in China registered for this device type
32catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HNZ
Manufacturer City Province Registered as Device types
Malosa Medical Instruments (Changshu) Limited Changshu Jiangsu Contract manufacturer 24
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
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 Ambler Surgical
Listed by Ambler Surgical, LLC, United States
FDA product code HNZ
Device type Curette, Ophthalmic
Device class Class 1
Regulation 21 CFR 886.4350
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2021-01-04

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Ambler Surgical
Catalogue number Size Status
Meyerhoeffer chalazion curette In distribution
Shepherd anterior/posterior capsule polisher In distribution
Foreign body curette In distribution
Dahan trabecular meshwork scraper In distribution
Shepherd anterior/posterior capsule polisher In distribution
Heath chalazion ring curette In distribution
Scorsetti-Shepherd capsule polisher In distribution
Ambler capsule polishing sweeper/curette In distribution
Meyerhoeffer chalazion curette In distribution
Shepard capsule polishing curette In distribution
Whitman-Shepherd anterior/posterior capsule polisher In distribution
Ambler capsule polishing sweeper In distribution
Pepose micro capsule polishing curette In distribution
Hu capsule polishing curette In distribution
Meyerhoeffer chalazion curette In distribution
Rentsch capsule polishing curette In distribution
Foreign body curette In distribution
Gills-Welsh capsule polishing curette In distribution
Nightingale posterior capsule polishing curette In distribution
Heath chalazion ring curette In distribution
Meyerhoeffer chalazion curette In distribution
Safran capsule polishing sweeper In distribution
Meyerhoeffer chalazion curette In distribution
Shepherd anterior/posterior capsule polisher In distribution
Rentsch capsule polishing curette In distribution
Hu capsule polishing curette In distribution
Anis capsule polisher In distribution
Meyerhoeffer chalazion curette In distribution
Skeele curette In distribution
Meyerhoeffer chalazion curette In distribution
Heath chalazion ring curette In distribution
Holladay posterior capsule polisher/curette In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Curette Katena Products, Inc. 28
MSI Precision Specialty Instruments MED Saver, Inc. 24
Walcott Rx Products Walcott Rx Product Inc 21
Stephens Instruments Krishna Imports Inc 21
Integra® Jarit® Integra LifeSciences Production Corporation 17
Sklar® Sklar Corporation 17
Integra® Miltex® Integra LifeSciences Production Corporation 16
Millennium Avalign Technologies, Inc. 16
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 11
Bausch + Lomb Bausch & Lomb Incorporated 11
Wexler Surgical, Inc. Wexler Surgical, Inc. 10
Meyerhoefer-Chalazion Curette Sontec Instruments, Inc. 10

Showing 12 of 54. All products under Curette, 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