What is FDA product code OFL?

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.

Stradis Medical, LLC. · Percutaneous Sheath Introducer Kit → Cardiovascular

Name: Stradis Medical, LLC.
Brand: Stradis Medical, LLC.

2manufacturers in China registered for this device type

2catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (1), Shanghai (1).

Chinese manufacturers registered for FDA product code OFL
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71
Shanghai INT Medical Instruments Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	10

Record

Regulatory record for Stradis Medical, LLC.
Listed by	Stradis Healthcare, United States
FDA product code	OFL
Device type	Percutaneous Sheath Introducer Kit
Device class	Class 2
Regulation	21 CFR 870.1340
Record published	2018-08-24
Record revised	2024-03-20 (version 5)

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
Packaging	Outer carton of 10, inner carton of 5, outer box of 20
Distribution end date	2023-01-04

Catalogue Numbers

Catalogue numbers for Stradis Medical, LLC.
Catalogue number	Size	Status
525-038		In distribution
525-038 R1		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Micro-Introducer Kit	Galt Medical Corp.	53
Micro-Access Tearaway Introducer Kit	Galt Medical Corp.	49
Tearaway Introducer Kit	Galt Medical Corp.	35
Stiffen Micro-Introducer Kit	Galt Medical Corp.	28
Elite Transitionless Micro-Introducer Kit	Galt Medical Corp.	24
Valved Tearaway Kit	Galt Medical Corp.	24
Typenex Introducer Set	Typenex Medical, LLC	23
Transitionless Micro-Introducer Kit	Galt Medical Corp.	20
Transitionless Stiffen Micro-Introducer Kit	Galt Medical Corp.	19
Seamless™	B. Braun Medical Inc.	19
Stradis	Stradis Healthcare	16
TVS LPA	Galt Medical Corp.	13

Showing 12 of 40. All products under Percutaneous Sheath Introducer Kit

Recalls Naming This Product

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

Recalls naming the identifiers of Stradis Medical, LLC.
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Stradis Medical, LLC dba Stradis Healthcare	UDI-DI	2022-11-02	Class II	Packaging process control	Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.	180 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.

Stradis Medical, LLC.