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
2manufacturers in China registered for this device type
137catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1).
| 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
| 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
| 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 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
| 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.