What is FDA product code PZG?

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Ophthalmic › SurgicalSurgical Eye Tray

Rayner Cataract Set 12

Name: Rayner Cataract Set 12
Brand: Rayner Cataract Set 12

Catalogue number HA-SET012, listed by Hasa Optix, Belgium, under Surgical Eye Tray. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Zhejiang (1), Hubei (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PZG
Manufacturer	City	Province	Registered as	Device types
Malosa Medical Instruments (Changshu) Limited	Changshu	Jiangsu	Contract manufacturer	24
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71
Hubei Lanbin Medical Group Co., Ltd.	Xiaogan	Hubei	Contract manufacturer	33

Record

Regulatory record for Rayner Cataract Set 12
Listed by	Hasa Optix, Belgium
FDA product code	PZG
Device type	Surgical Eye Tray
Device class	Class 1
Regulation	21 CFR 886.4350
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2023-11-13

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature 0 to 40 °C; Special storage condition: Keep dry; Keep away form the sunlight, storage temperature 0-40°C,

Catalogue Numbers

Catalogue numbers for Rayner Cataract Set 12
Catalogue number	Size	Per pack	Status
HA-SET012		10	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Readypak	Beaver-Visitec International, Ltd	72
Stradis Healthcare	Stradis Healthcare	49
Stradis	Stradis Healthcare	17
Kaiser Permanente Kit Pack	Oasis Medical, Inc.	16
Surgeon’s Choice Card	Oasis Medical, Inc.	16
CustomEyes®	Beaver-Visitec International, Ltd	9
Anodyne Surgical	Psi/Eye-Ko, Inc.	7
Beaver-Visitec	Beaver-Visitec International, Ltd	6
Invenio	GRI Medical & Electronic Technology Co., Ltd.	3
Stockton Kit 2	Blink Medical Ltd	2
Cataract Inst Set – Spokane Anderson	Blink Medical Ltd	2
Sub Tenon Set – Fine Tip	Blink Medical Ltd	2

Showing 12 of 79. All products under Surgical Eye Tray

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.