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.

Medline Industries, Inc. · Suture Kit → General & Plastic Surgery

Name: Medline Industries, Inc.
Brand: Medline Industries, Inc.

2manufacturers in China registered for this device type

8catalogue 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 Medline Industries, Inc.
Listed by	Medline 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	2016-09-29
Record revised	2023-07-28 (version 10)

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
Packaging	Case of 16, case of 24, case of 20
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Medline Industries, Inc.
Catalogue number	Size	Status
DYNJ39341C		In distribution
DYNJ39341D		In distribution
DYNDS1130A		In distribution
DYNJ17497D		In distribution
DYNDL1830		In distribution
DYNDA1823		In distribution
P903933B		In distribution
DYNDA1825		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
DeRoyal	Deroyal Industries, Inc.	7
Vygon	Vygon Corp.	6
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

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Medline Industries, Inc.
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Medline Industries, LP – Northfield	UDI-DI	2025-12-12	Class II	Nonconforming Material/Component	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.	60 units

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.

Medline Industries, Inc.