What is FDA product code MCY?

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 Hospital › TherapeuticWound Dressing Kit

ZipSeal 16 Surgical Skin Closure Kit

Name: ZipSeal 16 Surgical Skin Closure Kit
Brand: ZipSeal 16 Surgical Skin Closure Kit

Catalogue number PS1163, listed by Stryker GmbH, Switzerland, under Wound Dressing Kit. 12 manufacturers in China are registered for this product code.

Registry build 21.09.26

12manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Zhejiang (5), Hubei (2), Fujian (2).

Chinese manufacturers registered for FDA product code MCY
Manufacturer	City	Province	Registered as	Device types
Huzhou Junda Industry Co., Ltd.	Anji	Zhejiang	Contract manufacturer	129
Zhejiang Lidesen Medical Instrument Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	100
Anji Spenq Industrial Co., Ltd.	Huzhou	Zhejiang	Manufacturer	85
Hubei Qianjiang Kingphar Medical Material Co., Ltd.	Qianjiang	Hubei	Contract manufacturer	52
Jcmed Tianjin Import AND Export Co., Ltd.	Tianjin	Tianjin	Manufacturer	51
Anji Hongde Medical Products Co., Ltd.	Huzhou	Zhejiang	Contract manufacturer	47
Bestreat Safety & First AID Solution Co., Ltd.	Wuhan	Hubei	Manufacturer	35
Xiamen Ortocare Sports Health Co., Ltd.	Xiamen Free Trade Zone	Fujian	Contract manufacturer	32
Taizhou Rich Medical Products Co., Ltd.	Taizhou	Jiangsu	Contract manufacturer	20
Anji Fang Yuan Sanitary Material Co., Ltd.	Anji	Zhejiang	Repacker / relabeller	13
Shandong Succare Medical Co., Ltd.	Zibo	Shandong	Manufacturer	12
Ayida (Xiamen) P&C Technology Co., Ltd.	Xiamen	Fujian	Manufacturer	8

Record

Regulatory record for ZipSeal 16 Surgical Skin Closure Kit
Listed by	Stryker GmbH, Switzerland
FDA product code	MCY
Device type	Wound Dressing Kit
Device class	Class 2
Regulation	21 CFR 880.5075
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2019-01-30
Record revised	2021-07-02 (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
Storage	Storage environment temperature 5 to 25 °C
Sizes	Total volume 0.8 ml; length 16 cm

Catalogue Numbers

Catalogue numbers for ZipSeal 16 Surgical Skin Closure Kit
Catalogue number	Size	Status
PS1163	Total Volume 0.8 ml	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline Industries, Inc.	Medline Industries, Inc.	1,221
Medline	Medline Industries, Inc.	184
Stradis Medical, LLC.	Stradis Healthcare	116
Busse Hospital Disposables	Robert Busse & Co., Inc.	24
Centurion	Centurion Medical Products Corporation	24
Centurion Medical Products Corp	Medline Industries, Inc.	15
Wound CareKit	Mirodx, LLC	12
LSL Healthcare	Lsl Industries, Inc.	12
DeRoyal	Deroyal Industries, Inc.	11
carePAC	Extremity Care	11
Medical Action Industries	Medical Action Industries, Inc.	8
Curaplex	Bound Tree Medical, LLC	8

Showing 12 of 25. All products under Wound Dressing Kit

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.