Osseous Aluminium Splint Kit
External Aluminium Nasal Splint splinting of nasal dorsum after Rhinoplastly and providing support of nasal septal structure.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Hong Kong (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qibei Technology Co., Limited | Kl | Hong Kong | Manufacturer | 15 |
| Guangdong Meicen Medical Equipment Co., Ltd. | Foshan | Guangdong | Manufacturer | 7 |
Record
| Listed by | EON Meditech PVT. Ltd., India |
|---|---|
| FDA product code | EPP |
| Device type | Splint, Nasal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5800 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-07-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | 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 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E6149K | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aquaplast PS™ | Qfix | 82 |
| Denver Splint | Shippert Medical Technologies Corp. | 73 |
| Denver Splint | Summit Medical LLC | 67 |
| Splint, Nasal | Medtronic Xomed, Inc. | 33 |
| Splint, Nasal | Summit Medical LLC | 16 |
| Summit Medical | Summit Medical LLC | 13 |
| SurgiPlast Nasal Splint | Surgical Technology Laboratories Inc. | 12 |
| External thermoplastic nasal splint | Spiggle & Theis Medizintechnik Gmbh | 10 |
| Soft-Form™ ALD External Nasal Splint | Invotec International, Inc. | 8 |
| Splint, Nasal | Shippert Medical Technologies Corp. | 8 |
| External aluminium nasal splint | Spiggle & Theis Medizintechnik Gmbh | 7 |
| Soft-Form™ AL External Nasal Splint | Invotec International, Inc. | 6 |
Showing 12 of 45. All products under Splint, Nasal
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.