What is FDA product code OJU?

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

ACS · Skin Prep Tray → General & Plastic Surgery

Name: ACS
Brand: ACS

8manufacturers in China registered for this device type

4catalogue numbers in this listing

1recall

Who Else Makes It

Concentrated in Jiangsu (3), Anhui (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OJU
Manufacturer	City	Province	Registered as	Device types
Conod Medical Co., Limited	Changshu	Jiangsu	Contract manufacturer	48
Taizhou Xinkang Medical Materials Co., Ltd.	Taizhou	Jiangsu	Contract manufacturer	35
Conod Medical Shuyang Co., Ltd.	Shuyang	Jiangsu	Contract manufacturer	22
Sino Protection (Hefei) Medical Products Co., Ltd.	Hefei	Anhui	Contract manufacturer	18
Sterigenics Shanghai ETO Ltd.	Shanghai	Shanghai	Contract manufacturer	65
Xiamen Firstcare IMP. & EXP. Co., Ltd.	Xiamen	Fujian	Exporter	40
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.	Weihai	Shandong	Contract manufacturer	37
Anhui Medical Sterilizing Co., Ltd.	Hefei	Anhui	Contract manufacturer	8

Record

Regulatory record for ACS
Listed by	American Contract Systems, Inc.
FDA product code	OJU
Device type	Skin Prep Tray
Device class	Class 1
Regulation	21 CFR 878.4800
Premarket notification	Exempt
Record published	2020-12-16
Record revised	2022-06-17 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
Supplied sterile	Yes
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for ACS
Catalogue number	Size	Status
FLCR23C		In distribution
EFEP66B		In distribution
MHSS96O		In distribution
EFEP66A		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline Industries, Inc.	Medline Industries, Inc.	693
Cardinal Health	Cardinal Health 200, LLC	508
Centurion	Centurion Medical Products Corporation	43
Medical Action Industries	Medical Action Industries, Inc.	26
LSL Healthcare	Lsl Industries, Inc.	19
DeRoyal	Deroyal Industries, Inc.	13
Medline	Medline Industries, Inc.	8
Centurion Medical Products Corp	Medline Industries, Inc.	6
Skin Prep Tray	Carefusion 2200, Inc.	4
Medline	Centurion Medical Products Corporation	3
McKesson	Mckesson Medical-Surgical Inc.	2
MAI	Medical Action Industries, Inc.	2

Showing 12 of 16. All products under Skin Prep Tray

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	Closed
2020-04-13	Class II	Process control	The surgical gowns were manufactured in a facility that is not registered by the FDA.	2, 868 total kits	2020-11-25

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.

ACS