What is FDA product code OGP?

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

Anesthesiology › TherapeuticCricothyrotomy Kit

Wellead

Name: wellead
Brand: wellead

Cricothyrotomy kit, Type I, Cuffed, 6.0mm DEHP FREE (Sterile)

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code OGP
Manufacturer	City	Province	Registered as	Device types
Well Lead Medical Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	46

Record

Regulatory record for wellead
Listed by	Well Lead Medical Co., Ltd., China
FDA product code	OGP
Device type	Cricothyrotomy Kit
Device class	Class 2
Regulation	21 CFR 868.5800
Establishment	Contract manufacturer, Contract steriliser, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2021-10-15

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, manufacturing date
Packaging	Box of 10, carton of 10

Catalogue Numbers

Catalogue numbers for wellead
Catalogue number	Size	Status
10-0048		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Motion Medical Distributing	Haslam Medical, Inc.	25
Curaplex	Bound Tree Medical, LLC	23
NAR	North American Rescue, LLC.	13
Tactical CricKIT	North American Rescue, LLC.	9
Cardinal Health	Cardinal Health 200, LLC	8
NAR Kit	North American Rescue, LLC.	5
Forward	Synchronis Medical LLC	2
Endotracheal Kit	NAR Medical Depot, LLC	2
H&H Emergency Cricothyrotomy Kit	H & H Co.	1
TMM-CR-SO (Tactical Medical Module – Cricothyroidotomy Special Operations)	Altitude Technologies Inc.	1
Emergency Cric Kit	Safeguard US Operating, LLC	1
ReadyCric Kit	H & H Co.	1

Showing 12 of 22. All products under Cricothyrotomy Kit

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.