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 · Percutaneous Sheath Introducer Kit → Cardiovascular

Name: Stradis
Brand: Stradis

2manufacturers in China registered for this device type

16catalogue 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
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	2016-09-10
Record revised	2022-06-17 (version 6)

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
Sizes	Catheter gauge 4 to 5 Fr; length 11 to 70 cm; needle gauge 21 G; lumen/inner diameter 45 cm
Distribution end date	2023-02-09

Catalogue Numbers

Catalogue numbers for Stradis
Catalogue number	Size	Status
525-083	Length 70 cm	Withdrawn
525-027	Length 20 cm	Withdrawn
525-028	Length 35 cm	Withdrawn
525-072	Length 45 cm	Withdrawn
525-072		Withdrawn
525-038	Length 45 cm	Withdrawn
525-155	Catheter Gauge 5 Fr	Withdrawn
525-202	Length 45 cm	Withdrawn
525-065	Length 70 cm	Withdrawn
525-037	Length 45 cm	Withdrawn
525-038SA	Catheter Gauge 4 Fr	Withdrawn
525-029	Length 45 cm	Withdrawn
525-079	Length 11 cm	Withdrawn
525-038	Needle Gauge 21 G	Withdrawn
525-021	Length 45 cm	Withdrawn
525-462	Length 35 cm	Withdrawn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
TVS LPA	Galt Medical Corp.	13
GaltStick Introducer Kit	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
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