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.

General & Plastic Surgery › SurgicalSuture Removal Kit

AMSure ® Suture Removal KIT

Name: AMSure ® Suture Removal KIT
Brand: AMSure ® Suture Removal KIT

1 ea Gauze Sponge 3"(7.5cm) × 3"(7.5cm) 1 ea Littauer Scissors, 4.5"(11.5cm) 1 ea Plastic Forceps

Registry build 21.09.26

12manufacturers in China registered for this device type

3catalogue numbers in this listing

1510(k) clearance

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 AMSure ® Suture Removal KIT
Listed by	Amsino Medical Inc., United States
FDA product code	MCZ
Device type	Suture Removal Kit
Device class	Class 1
Regulation	21 CFR 878.4800
Establishment	Repacker / relabeller
510(k)	K050656
Record published	2026-04-03

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
Packaging	Case of 50

Catalogue Numbers

Catalogue numbers for AMSure ® Suture Removal KIT
Catalogue number	Size	Status
1		In distribution
1		In distribution
1		In distribution

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K050656	2005-05-02

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.