Ambler Surgical

Akahoshi MICS capsule polisher I/A tip, 22 gauge, straight, 1.1mm sandblasted ball tip, 45 degrees angled 0.3mm port, screw-in

Registry build 21.09.26
2manufacturers in China registered for this device type
9catalogue numbers in this listing

Who Else Makes It

All of them in Jiangsu.

Chinese manufacturers registered for FDA product code MXY
Manufacturer City Province Registered as Device types
66 Vision Tech Co., Ltd. Suzhou Jiangsu Private-label distributor 24
Belle Healthcare Technology Co., Ltd. Suzhou Jiangsu Manufacturer 20

Record

Regulatory record for Ambler Surgical
Listed by Ambler Surgical, LLC, United States
FDA product code MXY
Device type Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
Device class Class 1
Regulation 21 CFR 886.4350
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2021-01-07

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
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Ambler Surgical
Catalogue number Size Status
Akahoshi MICS capsule polisher I/A tip In distribution
Akahoshi MICS capsule polisher I/A tip In distribution
Akahoshi MICS capsule polisher I/A tip In distribution
Akahoshi MICS capsule polisher I/A tip In distribution
Akahoshi MICS capsule polisher I/A tip In distribution
Akahoshi MICS capsule polisher I/A tip In distribution
Akahoshi MICS capsule polisher I/A tip In distribution
Akahoshi MICS capsule polisher I/A tip In distribution
Akahoshi MICS capsule polisher I/A tip In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Anodyne Surgical Psi/Eye-Ko, Inc. 46
MSI Precision Specialty Instruments MED Saver, Inc. 11
Bausch + Lomb Bausch & Lomb Incorporated 8
Walcott Rx Products Psi/Eye-Ko, Inc. 6
Alcon Alcon Laboratories, Inc. 3
23ga Holekamp/Tano Drip Dropper™, Diamond Dusted Soft Tip, Fluted Katalyst Surgical, LLC 2
20ga Holekamp/Tano Drip Dropper™, Diamond Dusted Soft Tip, Fluted Katalyst Surgical, LLC 2
27ga Holekamp/Tano Drip Dropper™, Diamond Dusted Soft Tip Katalyst Surgical, LLC 2
25ga Holekamp/Tano Drip Dropper™, Diamond Dusted Soft Tip Katalyst Surgical, LLC 2
25ga Holekamp Drip Dropper™, Soft Tip, Fluted Katalyst Surgical, LLC 1
Kratz Capsule Polisher A1 Medical Gmbh 1
23ga Blunt Tip Cannula Katalyst Surgical, LLC 1

Showing 12 of 100. All products under Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal

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