What is FDA product code FWZ?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. 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.

General & Plastic Surgery › SurgicalOperating Room Accessories Table Tray

Budde®

Name: Budde®
Brand: Budde®

Budde® Halo Retractor Side Rail Support

Registry build 21.09.26

25manufacturers in China registered for this device type

2catalogue numbers in this listing

4recalls on this code

Who Else Makes It

Concentrated in Jiangsu (8), Zhejiang (4), Shanghai (4). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FWZ
Manufacturer	City	Province	Registered as	Device types
Ningbo Ningyuan Import & Export Co., Ltd.	Ningbo	Zhejiang	Contract manufacturer	80
Ningbo Castle Medical Import & Export Co., Ltd.	Ningbo	Zhejiang	Contract manufacturer	67
Hangzhou Fushan Medical Appliance Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	44
Lianyungang Bronson Non-woven Products Co., Ltd.	Lianyungang	Jiangsu	Contract manufacturer	16
Kunshan Jiehong Nonwoven Product Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	12
Fenglin Industry Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	10
Hubei Yinkang Medical Equipment Co., Ltd.	Xiaogan	Hubei	Contract manufacturer	8
Donghai Xingchen NON-Woven Products Co., Ltd.	North Donghai Development Zone, Lianyungang	Jiangsu	Contract manufacturer	7
Jiangyin Puremed	Jiangyin	Jiangsu	Contract manufacturer	7
Xinhua Surgical Instrument Co., Ltd.	Zibo	Shandong	Manufacturer	222
Suzhou Meccan Import and Export Corp.	Suzhou	Jiangsu	Contract manufacturer	71
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.	Weihai	Shandong	Contract manufacturer	37

Showing 12 of 25. All 25 manufacturers in China registered for Operating Room Accessories Table Tray

Record

Regulatory record for Budde®
Listed by	Integra Lifesciences Corporation, United States
FDA product code	FWZ
Device type	Operating Room Accessories Table Tray
Device class	Class 1
Regulation	21 CFR 878.4950
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2024-06-28
Record revised	2023-05-16 (version 3)

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Budde®
Catalogue number	Size	Status
A1067	16.4″ Length x 16.2″ Width x 5.7″ Height	In distribution
A1067	16.4″ Length x 16.2″ Width x 5.7″ Height	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
SchureMed	Schuerch Corporation	1,115
Allen	Hill-ROM, Inc.	258
Scanlan® Surg-I-Band® color coding	Scanlan International, Inc.	166
Operating Room Accessories Table Tray	MID Central Medical	151
Operating Room Accessories Table Tray	Smith & Nephew, Inc.	97
Schaerer Medical USA	Schaerer Medical USA Inc	96
TSI	Tedan Surgical Innovations, L.L.C.	87
De Mayo D2® Knee Positioner®	Innovative Medical Products, Inc.	77
MorphBoard®	Innovative Medical Products, Inc.	73
AXS	Axcess Surgical Innovations, LLC	72
Mayfield®	Integra Lifesciences Corporation	69
De Mayo Knee Positioner®	Innovative Medical Products, Inc.	62

Showing 12 of 340. All products under Operating Room Accessories Table Tray

Recalls

3 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	Closed
2014-12-19	Class II	Nonconforming Material/Component	Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use.	1053 Units	2017-02-22
2012-12-21	Class II	Device Design	Integra determined there is a possibility that the Base Units may break during use.	96 units	2013-07-10
2012-11-05	Class II	Under Investigation by firm	An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm’s Mayfield Composite Series Base Units and Mayfield Skull C	5 base units were distributed	2014-02-21
2010-05-19	Not classified	Labeling mix-ups	Storage case incorrectly labeled. The labels were for the Infinity XR2 Skull Clamp storage containers but were inadvertently placed on the Infinity XR2 Base Unit storage cases.	13 Units	2011-10-27

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.