Aurotrocar

Trocar set is a sterile single use medical device consisting of Stainless steel Trocar needle glued to a plastic handle in which the Cannula appended with valved silicone closure valve…

Registry build 21.09.26

Trocar set is a sterile single use medical device consisting of Stainless steel Trocar needle glued to a plastic handle in which the Cannula appended with valved silicone closure valve slides over it. This assembly is secured by a plastic cap. It is supplied along with one silicone tube inserted with an infusion adaptor and a Luer lock adaptor on either ends which is called as infusion line. A Trocar set encompasses 3 Trocar handle with cap and one infusion line.

2manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

All of them in Jiangsu.

Chinese manufacturers registered for FDA product code NGY
Manufacturer City Province Registered as Device types
Belle Healthcare Technology Co., Ltd. Suzhou Jiangsu Manufacturer 20
Victor Medical Instruments Co., Ltd. Changzhou Jiangsu Manufacturer 5

Record

Regulatory record for Aurotrocar
Listed by Aurolab, India
FDA product code NGY
Device type Cannula, Trocar, Ophthalmic
Device class Class 1
Regulation 21 CFR 886.4350
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-06-27

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date
Distribution end date 2023-06-29

Catalogue Numbers

Catalogue numbers for Aurotrocar
Catalogue number Size Status
ATS-23G Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Alcon Alcon Laboratories, Inc. 10
Cannula, Trocar, Ophthalmic Microvision, Inc. 7
Mani Infusion Cannula Mani, Inc. 6
Ophthalmic trocar FCI S A S FCI 20 22 4
Mani Trocar Mani, Inc. 3
Unity Alcon Laboratories, Inc. 3
Mani Trocar Kit Mani, Inc. 3
Rumex Rumex International Co. 3
Disposable one step single cannula including inserter. (25 gauge / 0.5 mm) D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. 3
23G High Flow infusion line D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. 2
27G High Flow infusion line D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. 2
Universal silicone infusion line for 20 gauge/0.9 mm cannula system. D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. 2

Showing 12 of 52. All products under Cannula, Trocar, 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