Hemopore
2 catalogue numbers from 5400222208S, listed by Stryker GmbH, Switzerland, under Splint, Intranasal Septal. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
2catalogue 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.
| 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
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | LYA |
| Device type | Splint, Intranasal Septal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4780 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-01-08 |
| Record revised | 2022-03-23 (version 2) |
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 |
| Storage | Storage environment temperature up to 8 °C |
| Packaging | Pack of 2, pack of 8 |
| Sizes | Length 8 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5400222208S | In distribution | |
| 5400020208 | Length 8.0 cm | In distribution |
Same 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 |
| Husteon Nasal | Medifab Co., Ltd. | 18 |
| 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 |
Showing 12 of 94. All products under Splint, Intranasal Septal
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Stryker Instruments | UDI-DI | 2025-02-25 | Class II | Under Investigation by firm | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. | 182,344 total units |
| Stryker Instruments | UDI-DI | 2025-02-25 | Class II | Under Investigation by firm | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. | 182,344 total units |
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.