Osseous PVA Corneal Light Shield

3 catalogue numbers from E7142, listed by EON Meditech PVT. Ltd., India, under Ear Wick. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26
2manufacturers in China registered for this device type
3catalogue numbers in this listing

Who Else Makes It

All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KCN
Manufacturer City Province Registered as Device types
Huizhou Foryou Medical Devices Co., Ltd. Huizhou Guangdong Contract manufacturer 18
Shenzhen JPY ION-Tech. Co., Ltd. Shenzhen Guangdong Contract manufacturer 20

Record

Regulatory record for Osseous PVA Corneal Light Shield
Listed by EON Meditech PVT. Ltd., India
FDA product code KCN
Device type Ear Wick
Device class Class 1
Regulation 21 CFR 874.5220
Establishment Contract manufacturer, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2024-07-05

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature 0 to 25 °C
Packaging Laminated box of 20
Sizes Height 7 to 8 mm; length 10 mm

Catalogue Numbers

Catalogue numbers for Osseous PVA Corneal Light Shield
Catalogue number Size Status
E7142 Height 7 mm In distribution
E7143 Height 8 mm In distribution
E7144 Length 10 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Osseous EON Meditech PVT. Ltd. 30
Merocel® Medtronic Xomed, Inc. 16
Netcell Network Medical Products, Ltd. 15
Fabco First AID Bandage Co Inc 8
Ear Wick Summit Medical LLC 7
Collin Network Medical Products, Ltd. 6
Otocell® Ear Wick Boston Medical Products, Inc. 4
Gyrus Acmi Gyrus Acmi, Inc. 4
Ultracell® Beaver-Visitec International, Ltd 3
Osseous PVA LASIK Eye Drain EON Meditech PVT. Ltd. 2
Osseous PVA Lasik EYE EON Meditech PVT. Ltd. 2
Pope Oto-Wick® Medtronic Xomed, Inc. 1

Showing 12 of 24. All products under Ear Wick

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer