Osseous Internal Nasal Airways Splint – Large
Catalogue number E3147L, listed by EON Meditech PVT. Ltd., India, under Splint, Nasal. 2 manufacturers in China are registered for this product code.
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 | 2024-07-03 |
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 | Length 84.5 mm; width 40 mm; height 1 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E3147L | Length 84.50 mm | 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.