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

Vygon

Name: Vygon
Brand: Vygon

6 catalogue numbers from AMS-8307-1, listed by Vygon Corp., 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

6catalogue numbers in this listing

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 Vygon
Listed by	Vygon Corp., United States
FDA product code	OVN
Device type	Suture Kit
Device class	Class 2
Regulation	21 CFR 878.4830
Record published	2020-12-09
Record revised	2022-11-28 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Packaging	Pack of 20, pack of 24

Catalogue Numbers

Catalogue numbers for Vygon
Catalogue number	Size	Status
AMS-8307-1		In distribution
AMS-8226		In distribution
AMS-8307-1		In distribution
AMS-8368		In distribution
AMS-8226		In distribution
AMS-8047		In distribution

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
ACS	American Contract Systems, Inc.	5
McKesson	Mckesson Medical-Surgical Inc.	3
Regard™	Resource Optimization & Innovation, L.L.C.	2

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.