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

Topica Laceration Closure Tray

Name: Topica Laceration Closure Tray
Brand: Topica Laceration Closure Tray

The Topical Laceration Closure Tray contains everything needed to topically close uncomplicated laceration and skin avulsions that would otherwise be closed with sutures. The TLC tray…

Registry build 21.09.26

The Topical Laceration Closure Tray contains everything needed to topically close uncomplicated laceration and skin avulsions that would otherwise be closed with sutures. The TLC tray contains the T-RING digit tourniquet, the T-Strip wound closure mesh, topical lidocaine gel, 3″ x 3″ gauze, scissors and benzoin ampule. T-Strip is ideal for Topical Laceration Closure, and is designed to be used with the T-RING digit tourniquet to treat most uncomplicated finger lacerations. The T-Strip can also be used alone to treat superficial lacerations and skin avulsions that occur on other parts of the body. Using the T-Strip and a topical skin adhesive often eliminates the need for laceration trays, painful injections, and sutures; allowing most repairs to be completed in minutes.

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 Topica Laceration Closure Tray
Listed by	Precision Medical Devices Inc, United States
FDA product code	OVN
Device type	Suture Kit
Device class	Class 2
Regulation	21 CFR 878.4830
Establishment	Specification developer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2025-06-14

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
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, manufacturing date
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Topica Laceration Closure Tray
Catalogue number	Size	Per pack	Status
TLC 001		25	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
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.