What is FDA product code NGY?

The trocar/cannula set is a manual surgical instrument intended for use as single-use, disposable cannula system for establishing an entry site conduit for passing ophthalmic instruments used to perform posterior ophthalmic surgical procedures.

Ophthalmic › SurgicalCannula, Trocar, Ophthalmic

Trocar 20g With Removable Valve

Name: Trocar 20g with removable valve
Brand: Trocar 20g with removable valve

Catalogue number AK-0346/N, listed by Aktive SRL, Italy, under Cannula, Trocar, Ophthalmic. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

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 Trocar 20g with removable valve
Listed by	Aktive SRL, Italy
FDA product code	NGY
Device type	Cannula, Trocar, Ophthalmic
Device class	Class 1
Regulation	21 CFR 886.4350
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2023-06-12

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
Storage	Storage environment temperature 5 to 40 °C

Catalogue Numbers

Catalogue numbers for Trocar 20g with removable valve
Catalogue number	Size	Per pack	Status
AK-0346/N	GAUGE	6	In distribution

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.