What is FDA product code OGQ?

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

General Hospital › MiscellaneousEar Irrigation Kit

Ear Wax Removal Kit 12 Ct. Case

Name: Ear Wax Removal Kit 12 Ct. Case
Brand: Ear Wax Removal Kit 12 Ct. Case

Catalogue number 704, listed by Bionix, LLC, United States, under Ear Irrigation Kit. 17 manufacturers in China are registered for this product code.

Registry build 21.09.26

17manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Guangdong (9), Zhejiang (4), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OGQ
Manufacturer	City	Province	Registered as	Device types
Ningbo Albert Novosino Co., Ltd.	Yuyao	Zhejiang	Contract manufacturer	17
Jiangsu Shenli Medical Production Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	6
Shanghai Jolly Industrial Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	99
Shanghai Lions Industrial Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	82
Hangzhou Weize IMP & EXP Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	34
Aimi Health Technology (Guangdong) Co., Ltd.	Dongguan	Guangdong	Manufacturer	21
Wenzhou Zuoyou Medical Technoloyg Co., Ltd.	Wenzhou	Zhejiang	Contract manufacturer	21
Ningbo Cooskin Stationery Co., Ltd.	Ningbo	Zhejiang	Manufacturer	18
Dongguan Yipincheng Technology Co., Ltd.	Dongguan	Guangdong	Manufacturer	17
Shenzhen Obestec Industrial Co., Ltd.	Shenzhen	Guangdong	Manufacturer	14
Shenzhen Heearly Technology Co., Ltd.	Bao An District, Shenzhen	Guangdong	Contract manufacturer	13
Guangdong Okay Technology Co., Ltd.	Zhong Shan	Guangdong	Manufacturer	10

Showing 12 of 17. All 17 manufacturers in China registered for Ear Irrigation Kit

Record

Regulatory record for Ear Wax Removal Kit 12 Ct. Case
Listed by	Bionix, LLC, United States
FDA product code	OGQ
Device type	Ear Irrigation Kit
Device class	Class 1
Regulation	21 CFR 880.6960
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2022-10-27
Record revised	2023-07-17 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, manufacturing date
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Ear Wax Removal Kit 12 Ct. Case
Catalogue number	Size	Per pack	Status
704		12	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Doctor Easy Medical Products	Doctor Easy Medical Products Corporation	5
Centurion	Centurion Medical Products Corporation	4
Cleanse Right	Blue Echo Care	3
caring mill	Blue Echo Care	2
Medi Grade	Ningbo Albert Novosino Co., Ltd.	2
Ezy Dose Self-Care	Apothecary Products, LLC.	1
Conformis Hip System	ConforMIS, Inc.	1

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.