Osseous

Ear PVA Dressings sponges are designed to be placed inside ear canal for use as temporary tamponade or heamostatis device to control blood oozing or persistent bleeding and aid the…

Registry build 21.09.26

Ear PVA Dressings sponges are designed to be placed inside ear canal for use as temporary tamponade or heamostatis device to control blood oozing or persistent bleeding and aid the treatment of otitis external.

2manufacturers in China registered for this device type
30catalogue 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
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 2024-06-11

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature up to 25 °C
Packaging Laminated box of 10, laminated box of 20
Sizes Outer diameter 9 to 12 mm; length 15 to 24 mm

Catalogue Numbers

Catalogue numbers for Osseous
Catalogue number Size Status
E7161 Outer Diameter 9 mm In distribution
E7167-OC Outer Diameter 12 mm In distribution
E7162-OC Outer Diameter 9 mm In distribution
E7170 Outer Diameter 09 mm In distribution
E7169-OC Outer Diameter 09 mm In distribution
E7169 Outer Diameter 09 mm In distribution
E7163 Outer Diameter 12 mm In distribution
E7162-O Outer Diameter 9 mm In distribution
E7168 Outer Diameter 12 mm In distribution
E7165-OC Outer Diameter 09 mm In distribution
E7164-O Outer Diameter 12 mm In distribution
E7168-O Outer Diameter 12 mm In distribution
E7165 Outer Diameter 09 mm In distribution
E7168-OC Outer Diameter 12 mm In distribution
E7163-OC Outer Diameter 12 mm In distribution
E7162 Outer Diameter 9 mm In distribution
E7169-O Outer Diameter 09 mm In distribution
E7161-OC Outer Diameter 09 mm In distribution
E7170-OC Outer Diameter 09 mm In distribution
E7165-O Outer Diameter 09 mm In distribution
E7170-O Outer Diameter 09 mm In distribution
E7166 Outer Diameter 09 mm In distribution
E7166-OC Outer Diameter 09 mm In distribution
E7167 Outer Diameter 12 mm In distribution
E7164-OC Outer Diameter 12 mm In distribution
E7163-O Outer Diameter 12 mm In distribution
E7164 Outer Diameter 12 mm In distribution
E7167-O Outer Diameter 12 mm In distribution
E7161-O Outer Diameter 09 mm In distribution
E7166-O Outer Diameter 09 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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 Corneal Light Shield EON Meditech PVT. 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