What is FDA product code MCZ?

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.

Stradis Medical, LLC · Suture Removal Kit → General & Plastic Surgery

Name: Stradis Medical, LLC
Brand: Stradis Medical, LLC

12manufacturers in China registered for this device type

2catalogue numbers in this listing

1recall

Who Else Makes It

Concentrated in Jiangsu (6), Zhejiang (2), Hubei (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MCZ
Manufacturer	City	Province	Registered as	Device types
Conod Medical Co., Limited	Changshu	Jiangsu	Contract manufacturer	48
Allmed Medical Products Co., Ltd.	Zhijiang	Hubei	Contract manufacturer	43
Primecare Medical (Suzhou) Co., Ltd.	Changshu	Jiangsu	Contract manufacturer	20
Derma Sciences Nantong Incorporation	Development	Jiangsu	Contract manufacturer	19
Jiangsu Classic NEW-Type Medical Products Co., Ltd.	Yancheng	Jiangsu	Contract manufacturer	13
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146
Zhejiang Lidesen Medical Instrument Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	100
Amsino Medical (Kunshan) Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	53
Allmed Industrial Limited	Shenzhen	Guangdong	Manufacturer	42
Hubei Lanbin Medical Group Co., Ltd.	Xiaogan	Hubei	Contract manufacturer	33
Hangzhou Primecare Medical Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29
Excellent Medical Technology Co., Ltd.	Hong Kong	Hong Kong	Specification developer	17

Record

Regulatory record for Stradis Medical, LLC
Listed by	Stradis Healthcare, United States
FDA product code	MCZ
Device type	Suture Removal Kit
Device class	Class 1
Regulation	21 CFR 878.4800
Record published	2017-12-12
Record revised	2023-02-10 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Outer box of 50, outer box of 20
Distribution end date	2023-02-09

Catalogue Numbers

Catalogue numbers for Stradis Medical, LLC
Catalogue number	Size	Status
ZZ-0958		In distribution
SR-1000		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	166
Medical Action Industries	Medical Action Industries, Inc.	99
Centurion	Centurion Medical Products Corporation	71
Medline Industries, Inc.	Medline Industries, Inc.	48
LSL Healthcare	Lsl Industries, Inc.	42
Medline	Medline Industries, Inc.	42
E.M Adams Co., Inc.	E.M. Adams Co., Inc.	33
Novaplus®	Medical Action Industries, Inc.	16
McKesson	Mckesson Medical-Surgical Inc.	11
Trinity Sterile, Inc.	Trinity Sterile, Inc.	10
Stradis Healthcare	Stradis Healthcare	8
Centurion Medical Products Corp	Medline Industries, Inc.	8

Showing 12 of 35. All products under Suture Removal Kit

Recalls

1 of these is 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
2022-04-22	Class II	Under Investigation by firm	There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.	7340 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.

Stradis Medical, LLC