Ambler Surgical

Interchangeable-Tip I/A system straight tip, 16 gauge outer sleeve, 21 gauge inner sleeve, 0.5mm aspiration port for rapid removal of visco material, stainless steel

Registry build 21.09.26
2manufacturers in China registered for this device type
137catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (1), Guangdong (1).

Chinese manufacturers registered for FDA product code KYG
Manufacturer City Province Registered as Device types
Sihong Ophsurin Co., Ltd. Suqian Jiangsu Manufacturer 17
Shenzhen Create Technology Co., Ltd. Shenzhen Guangdong Manufacturer 9

Record

Regulatory record for Ambler Surgical
Listed by Ambler Surgical, LLC, United States
FDA product code KYG
Device type Device, Irrigation, Ocular Surgery
Device class Class 1
Regulation 21 CFR 886.4360
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
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Ambler Surgical
Catalogue number Size Status
Bimanual irrigation tip In distribution
Interchangeable-Tip I/A system straight silicone sleeve tip In distribution
Interchangeable-Tip I/A system 150 degrees binkhorst return tip In distribution
Interchangeable-Tip I/A system 90 degrees angled silicone sleeve tip In distribution
Interchangeable-Tip I/A system 45 degrees angled capsule polishing tip In distribution
Interchangeable-Tip I/A system replacement o-rings In distribution
Interchangeable-Tip I/A system curved silicone sleeve tip In distribution
Interchangeable-Tip I/A system straight silicone sleeve tip In distribution
Interchangeable-Tip I/A system replacement o-rings In distribution
Uni-Flow II threaded I/A handpiece In distribution
Bimanual aspiration tip In distribution
Bimanual aspiration tip In distribution
Interchangeable-Tip I/A system luer adapter In distribution
Bimanual irrigation tip In distribution
Bimanual irrigation tip In distribution
Interchangeable-Tip I/A system curved tip In distribution
Bimanual irrigation tip In distribution
Test chambers In distribution
Bimanual aspiration handpiece In distribution
Interchangeable-Tip I/A system universal handle In distribution
Bimanual irrigation unibody handpiece In distribution
Male to male cannula adapter In distribution
Interchangeable-Tip I/A system straight tip In distribution
Kansas infusion handpiece In distribution
Interchangeable-Tip I/A system straight tip In distribution
Bimanual irrigation tip In distribution
Interchangeable-Tip I/A system curved silicone sleeve tip In distribution
Interchangeable-Tip I/A system 45 degrees angled silicone sleeve tip In distribution
Interchangeable-Tip I/A system threaded I/A adapter In distribution
Interchangeable-Tip I/A system straight tip In distribution
Interchangeable-Tip I/A system 45 degrees angled silicone sleeve tip In distribution
Interchangeable-Tip I/A system curved silicone sleeve tip In distribution
Irrigating/Aspirating cannula handpiece In distribution
Bimanual aspiration unibody handpiece In distribution
Ambler I/A tip In distribution
Interchangeable-Tip I/A system 45 degrees angled tip In distribution
I/A unibody handpiece In distribution
Bimanual irrigation tip In distribution
McIntyre handpiece for aspirating or irrigating In distribution
Bimanual irrigation tip In distribution
Bimanual irrigation tip In distribution
Interchangeable-Tip I/A system 45 degrees angled tip In distribution
Interchangeable-Tip I/A system 45 degrees angled tip In distribution
Interchangeable-Tip I/A system straight tip In distribution
Bimanual aspiration unibody handpiece In distribution
Interchangeable-Tip I/A system extra silicone sleeves In distribution
Irrigating/Aspirating cannula handpiece In distribution
Interchangeable-Tip I/A system 45 degrees angled tip In distribution
Cleaning/flushing kit In distribution
Uni-Flow I threaded I/A handpiece In distribution
Bimanual aspiration tip In distribution
I/A unibody handpiece In distribution
Interchangeable-Tip I/A system luer adapter In distribution
Bimanual irrigation tip In distribution
Interchangeable-Tip I/A system 90 degrees angled tip In distribution
Bimanual aspiration tip In distribution
Irrigating/Aspirating cannula handpiece In distribution
McIntyre handpiece for aspirating or irrigating In distribution
Bimanual irrigation tip In distribution
Interchangeable-Tip I/A system 45 degrees angled silicone sleeve tip In distribution
Interchangeable-Tip I/A system 90 degrees angled tip In distribution
Interchangeable-Tip I/A system curved tip In distribution
Bimanual irrigation handpiece In distribution
Bimanual aspiration tip In distribution
Bimanual aspiration tip In distribution
Interchangeable-Tip I/A system 90 degrees angled silicone sleeve tip In distribution
Interchangeable-Tip I/A system 45 degrees angled In distribution
Bimanual irrigation tip In distribution
Bimanual aspiration tip In distribution
Interchangeable-Tip I/A system 45 degrees angled tip In distribution
Bimanual irrigation tip In distribution
Bimanual aspiration unibody handpiece In distribution
Interchangeable-Tip I/A system straight silicone sleeve tip In distribution
Bimanual aspiration unibody handpiece In distribution
Interchangeable-Tip I/A system 45 degrees angled capsule polishing tip In distribution
Interchangeable-Tip I/A system straight silicone sleeve tip In distribution
Ambler infusion handle In distribution
Irrigating/Aspirating cannula handpiece In distribution
Bimanual aspiration tip In distribution
Interchangeable-Tip I/A system 150 degrees binkhorst return tip In distribution
Interchangeable-Tip I/A system 90 degrees angled silicone sleeve tip In distribution
Interchangeable-Tip I/A system 45 degrees angled silicone sleeve tip In distribution
Bimanual irrigation tip In distribution
Bimanual irrigation unibody handpiece In distribution
Interchangeable-Tip I/A system 90 degrees angled tip In distribution
Infusion handle In distribution
Bimanual aspiration tip In distribution
Ambler I/A tip In distribution
I/A unibody handpiece In distribution
DSAEK descemet’s membrane stripper replacement handle only In distribution
Female to female cannula adapter In distribution
Infusion handle In distribution
Bimanual aspiration tip In distribution
Interchangeable-Tip I/A system universal handle In distribution
Irrigating/Aspirating cannula handpiece In distribution
Interchangeable-Tip I/A system straight tip In distribution
Interchangeable-Tip I/A system luer adapter In distribution
Bimanual aspiration tip In distribution
Interchangeable-Tip I/A system 90 degrees angled tip In distribution
Bimanual irrigation tip In distribution
Interchangeable-Tip I/A system curved silicone sleeve tip In distribution
Interchangeable-Tip I/A system 90 degrees angled tip In distribution
Irrigating/Aspirating cannula handpiece replacement stainless steel adapter tip In distribution
Ambler I/A tip In distribution
Interchangeable-Tip I/A system 90 degrees angled silicone sleeve tip In distribution
Bimanual irrigation tip In distribution
Bimanual aspiration unibody handpiece In distribution
Interchangeable-Tip I/A system curved tip In distribution
Bimanual irrigation tip In distribution
Bimanual irrigation tip In distribution
Bimanual irrigation tip In distribution
Bimanual irrigation tip In distribution
Bimanual irrigation tip In distribution
Bimanual aspiration unibody handpiece In distribution
Interchangeable-Tip I/A system straight tip In distribution
Bimanual irrigation tip In distribution
Bimanual irrigation tip In distribution
Bimanual irrigation tip In distribution
Bimanula aspiration / irrigation tip replacement o-rings In distribution
Bimanual irrigation tip In distribution
Bimanual irrigation tip In distribution
Bimanual aspiration unibody handpiece In distribution
Bimanual irrigation tip In distribution
Bimanual irrigation unibody handpiece In distribution
Interchangeable-Tip I/A system curved tip In distribution
Interchangeable-Tip I/A system curved tip In distribution
Bimanual aspiration tip In distribution
Bimanual aspiration tip In distribution
Interchangeable-Tip I/A system luer adapter In distribution
Interchangeable-Tip I/A system 45 degrees angled In distribution
Interchangeable-Tip I/A system curved tip In distribution
Bimanual aspiration unibody handpiece In distribution
Ambler infusion handle In distribution
Male to male cannula adapter In distribution
Bimanual irrigation tip In distribution
Bimanual aspiration tip In distribution
Bimanual irrigation tip In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Rumex Rumex International Co. 20
Anodyne Surgical Psi/Eye-Ko, Inc. 17
Device, Irrigation, Ocular Surgery Geuder Aktiengesellschaft 17
High pressure injection/aspiration system for syringe – Connector A Aktive SRL 16
Phaco Accessory Set Medicel AG 14
MSI Precision Specialty Instruments MED Saver, Inc. 11
Bausch + Lomb Bausch & Lomb Incorporated 9
High pressure injection/aspiration system with syringe – Connector E Aktive SRL 8
Medetz Surgical Instruments Medetz Surgical Instruments 7
Device, Irrigation, Ocular Surgery Microvision, Inc. 3
MorTan Zien Medical Technologies LLC 3
Disposable Infusion Cannula, 6.0 mm. D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. 2

Showing 12 of 114. All products under Device, Irrigation, Ocular Surgery

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