What is FDA product code OFC?

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.

Cardiovascular › DiagnosticCatheter Introducer Kit

Landmark Catheter Introducer Kit

Name: Landmark Catheter Introducer Kit
Brand: Landmark Catheter Introducer Kit

The Landmark Catheter Introducer Kit is intended to aid in gaining vascular access, placement, and securing the Landmark REBOA Catheter to the patient. The suture in this kit is intended…

Registry build 21.09.26

The Landmark Catheter Introducer Kit is intended to aid in gaining vascular access, placement, and securing the Landmark REBOA Catheter to the patient. The suture in this kit is intended for temporary securement of the catheter clamp to the patient’s skin. The suture and clamp are to be removed immediately after the catheter is withdrawn.

1manufacturer

1catalogue number

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OFC
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71

Record

Regulatory record for Landmark Catheter Introducer Kit
Listed by	Zien Medical Technologies LLC, United States
FDA product code	OFC
Device type	Catheter Introducer Kit
Device class	Class 2
Regulation	21 CFR 870.1340
Establishment	Contract manufacturer, Specification developer, Manufacturer
Record published	2024-04-24

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
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Shipper of 5

Catalogue Numbers

Catalogue numbers for Landmark Catheter Introducer Kit
Catalogue number	Size	Status
LR-KIT		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	16
Prytime Medical Devices, Inc.	Prytime Medical Devices, Inc.	2
Lingeman Percutaneous Tract Kit	Boston Scientific Corporation	1
TorqMax Sheath Grip Accessory	Spectranetics Corp.	1
Percutaneous Tract Kit	Boston Scientific Corporation	1

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.