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.

Beaver-Visitec · Surgical Eye Tray → Ophthalmic

Name: Beaver-Visitec
Brand: Beaver-Visitec

3manufacturers in China registered for this device type

6catalogue numbers in this listing

6recalls on this code

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 Beaver-Visitec
Listed by	Beaver-Visitec International, Ltd, United Kingdom
FDA product code	PZG
Device type	Surgical Eye Tray
Device class	Class 1
Regulation	21 CFR 886.4350
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2021-11-15
Record revised	2022-02-17 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Beaver-Visitec
Catalogue number	Per pack	Status
MMK834/1	30	In distribution
MMK967	30	In distribution
MMK100/2	20	In distribution
MMK884	20	In distribution
MMK883/2	30	In distribution
MMK110/3	20	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
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
Stockton Kit 1	Blink Medical Ltd	2

Showing 12 of 79. All products under Surgical Eye Tray

Recalls

6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2021-11-17	Class II	Packaging change control	Kit packaging may have small holes compromising product sterility	920 units
2021-11-17	Class II	Packaging change control	Kit packaging may have small holes compromising product sterility	1170 units
2021-11-17	Class II	Packaging change control	Kit packaging may have small holes compromising product sterility	30 units
2021-11-17	Class II	Packaging change control	Kit packaging may have small holes compromising product sterility	680 units
2021-11-17	Class II	Packaging change control	Kit packaging may have small holes compromising product sterility	120 units
2021-11-17	Class II	Packaging change control	Kit packaging may have small holes compromising product sterility	380 units

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.

Beaver-Visitec