Husteon Nasal

18 catalogue numbers from HN080-3010, listed by Medifab Co., Ltd., South Korea, under Splint, Intranasal Septal. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26
3manufacturers in China registered for this device type
18catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (1), Shandong (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LYA
Manufacturer City Province Registered as Device types
Bioregen Biomedical (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 2
Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. Weifang Shandong Manufacturer 1
Zhejiang Meihua Dingchang Pharmaceutical Co., Ltd. Shaoxing Zhejiang Manufacturer 1

Record

Regulatory record for Husteon Nasal
Listed by Medifab Co., Ltd., South Korea
FDA product code LYA
Device type Splint, Intranasal Septal
Device class Class 1
Regulation 21 CFR 874.4780
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2022-07-01
Record revised 2023-02-22 (version 2)

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

Catalogue Numbers

Catalogue numbers for Husteon Nasal
Catalogue number Size Status
HN080-3010 In distribution
HNS100-4010 In distribution
HNSS100-3010 In distribution
HNS080-3010 In distribution
HN080-4010 In distribution
HNS050-3010 In distribution
HNS080-4010 In distribution
HNS100-3010 In distribution
HN050-3010 In distribution
HNSS100-4010 In distribution
HNSS050-3010 In distribution
HN100-4010 In distribution
HN100-3010 In distribution
HNSS080-4010 In distribution
HN050-4010 In distribution
HNS050-4010 In distribution
HNSS050-4010 In distribution
HNSS080-3010 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Netcell Network Medical Products, Ltd. 33
Invotec Silicone Sheeting Invotec International, Inc. 20
Septal splints Spiggle & Theis Medizintechnik Gmbh 20
Velnez Datt Mediproducts Private Limited 20
Husteon MeshNasal Medifab Co., Ltd. 20
Rhino Rocket Shippert Medical Technologies Corp. 17
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing Invotec International, Inc. 16
Splint, Intranasal Septal Shippert Medical Technologies Corp. 16
Exmoor Exmoor Plastics Limited 15
Nasal Hemostasis Sponge Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. 14
Orca Foam Orca Products LLC 13
Network Network Medical Products, Ltd. 13

Showing 12 of 94. All products under Splint, Intranasal Septal

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