What is FDA product code LRO?

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

Custom Assemblies, Inc. · General Surgery Tray → General & Plastic Surgery

Name: Custom Assemblies, Inc.
Brand: Custom Assemblies, Inc.

24manufacturers in China registered for this device type

2catalogue numbers in this listing

1recall

Who Else Makes It

Concentrated in Jiangsu (11), Anhui (6), Zhejiang (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 LRO
Manufacturer	City	Province	Registered as	Device types
Conod Medical Co., Limited	Changshu	Jiangsu	Contract manufacturer	48
Principle & Will Biotech (Pinghu) Co., Ltd.	Pinghu	Zhejiang	Contract manufacturer	39
Sino Protection (Hefei) Medical Products Co., Ltd.	Hefei	Anhui	Contract manufacturer	18
Changzhou Holymed Products Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	16
Donghai Xingchen NON-Woven Products Co., Ltd.	North Donghai Development Zone, Lianyungang	Jiangsu	Contract manufacturer	7
Fengyang Jiehong Nonwoven Product Co., Ltd.	Chuzhou	Anhui	Contract manufacturer	7
3A Medical Products Co., Ltd.	Liu An	Anhui	Contract manufacturer	6
Cobes Industries (Jinzhai) Co., Ltd.	Luan	Anhui	Contract manufacturer	6
Lianyungang Aiyeh Non-woven Products Co., Ltd.	Lianyungang	Jiangsu	Contract manufacturer	6
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146
Ningbo Greetmed Medical Instruments Co., Ltd.	Ningbo	Zhejiang	Specification developer	75
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71

Showing 12 of 24. All 24 manufacturers in China registered for General Surgery Tray

Record

Regulatory record for Custom Assemblies, Inc.
Listed by	Custom Assemblies, Inc., United States
FDA product code	LRO
Device type	General Surgery Tray
Device class	Class 2
Regulation	21 CFR 878.4370
Establishment	Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2023-09-13

Specifications

Specifications
MRI safety	MR Unsafe
Supplied sterile	Yes
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Custom Assemblies, Inc.
Catalogue number	Size	Status
CMS-8322-R1		In distribution
CMS-2012-R3		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	67,931
Medline Industries, Inc.	Medline Industries, Inc.	54,362
Avid TruCustom	Avid Medical, Inc.	13,498
Halyard	Avid Medical, Inc.	12,802
ACS	American Contract Systems, Inc.	10,337
SurgiTrack	Owens & Minor Distribution, Inc.	5,575
Aligned Medical Solutions	Aligned Medical Solutions	3,490
SurgiTrackSM	Owens & Minor Distribution, Inc.	3,364
DeRoyal	Deroyal Industries, Inc.	2,770
Medline	Medline Industries, Inc.	1,960
Henry Schein	Henry Schein, Inc.	729
Stradis	Stradis Healthcare	685

Showing 12 of 113. All products under General Surgery 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
2017-06-15	Class II	Material/Component Contamination	The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide” 22GA 1 inch Needles. BD subsequently recalled these needles because, ” Loose polypropylene particulate in the fluid path could be expelled out of th	2155 kits	2017-08-28

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.

Custom Assemblies, Inc.