What is FDA product code OVN?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://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 Kit

MAI-A

Name: MAI-A
Brand: MAI-A

Catalogue number 77514, listed by Medical Action Industries, Inc., United States, under Suture Kit. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Hubei (1), Zhejiang (1).

Chinese manufacturers registered for FDA product code OVN
Manufacturer	City	Province	Registered as	Device types
Hubei Lanbin Medical Group Co., Ltd.	Xiaogan	Hubei	Contract manufacturer	33
Ningbo Greatcare Medical Instruments Co., Ltd.	Ningbo	Zhejiang	Contract manufacturer	10

Record

Regulatory record for MAI-A
Listed by	Medical Action Industries, Inc., United States
FDA product code	OVN
Device type	Suture Kit
Device class	Class 2
Regulation	21 CFR 878.4830
Premarket notification	Exempt
Record published	2017-09-26
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Over the counter	Yes
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Storage	Special storage condition: STORE AT ROOM TEMPERATURE
Packaging	Pack of 20
Distribution end date	2017-12-12
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for MAI-A
Catalogue number	Size	Status
77514		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Deknatel	Teleflex Medical LLC	360
Medical Action Industries	Medical Action Industries, Inc.	326
Syneture	Covidien LP	321
Cardinal Health	Cardinal Health 200, LLC	220
LSL Healthcare	Lsl Industries, Inc.	41
Medichoice	Owens & Minor Distribution, Inc.	22
Novaplus®	Medical Action Industries, Inc.	20
Medline Industries, Inc.	Medline Industries, Inc.	8
DeRoyal	Deroyal Industries, Inc.	7
Vygon	Vygon Corp.	6
ACS	American Contract Systems, Inc.	5
McKesson	Mckesson Medical-Surgical Inc.	3

Showing 12 of 28. All products under Suture 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.