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.

Cardiovascular › DiagnosticPercutaneous Sheath Introducer Kit

Pediatric Tearaway Introducer Kit

Name: Pediatric Tearaway Introducer Kit
Brand: Pediatric Tearaway Introducer Kit

10 catalogue numbers from KIT-051-04, listed by Galt Medical Corp., United States, under Percutaneous Sheath Introducer Kit. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

10catalogue numbers in this listing

2recalls on this code

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 Pediatric Tearaway Introducer Kit
Listed by	Galt Medical Corp., United States
FDA product code	OFL
Device type	Percutaneous Sheath Introducer Kit
Device class	Class 2
Regulation	21 CFR 870.1340
Establishment	Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2018-02-06
Record revised	2024-03-20 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, serial number
Packaging	Shipper box of 25, shelf box of 5
Sizes	Catheter gauge 2 to 3 Fr

Catalogue Numbers

Catalogue numbers for Pediatric Tearaway Introducer Kit
Catalogue number	Size	Status
KIT-051-04	Catheter Gauge 3 Fr	In distribution
KIT-051-00	Catheter Gauge 2 Fr	In distribution
KIT-051-02	Catheter Gauge 2 Fr	In distribution
KIT-051-05	Catheter Gauge 3 Fr	In distribution
KIT-051-11	Catheter Gauge 3 Fr	In distribution
KIT-051-06	Catheter Gauge 3 Fr	In distribution
KIT-051-13	Catheter Gauge 2 Fr	In distribution
KIT-051-01	Catheter Gauge 2 Fr	In distribution
KIT-051-03	Catheter Gauge 2 Fr	In distribution
KIT-051-14	Catheter Gauge 2 Fr	In distribution

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 Pediatric Tearaway Introducer Kit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Galt Medical Corp.	UDI-DI	2025-03-27	Class II	Process control	Due to a potential open seal in the sterile barrier packaging.	490 units

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2025-03-27	Class II	Process control	Due to a potential open seal in the sterile barrier packaging.	4,280 kits

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.