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

TorqMax Sheath Grip Accessory

Name: TorqMax Sheath Grip Accessory
Brand: TorqMax Sheath Grip Accessory

Catalogue number 502-001, listed by Spectranetics Corp., United States, under Catheter Introducer Kit. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

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 TorqMax Sheath Grip Accessory
Listed by	Spectranetics Corp., United States
FDA product code	OFC
Device type	Catheter Introducer Kit
Device class	Class 2
Regulation	21 CFR 870.1340
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Record published	2015-02-06
Record revised	2024-08-21 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Special storage condition: Keep Dry
Packaging	Box of 2
Sizes	Outer diameter 7.5 mm

Catalogue Numbers

Catalogue numbers for TorqMax Sheath Grip Accessory
Catalogue number	Size	Status
502-001	Outer Diameter 7.5 mm	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
Percutaneous Tract Kit	Boston Scientific Corporation	1
Landmark Catheter Introducer Kit	Zien Medical Technologies LLC	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K093257	2010-03-26

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.