Custom Nasal Splint
Size: 0.50 x 51 x 76 mm; Type: Silicone
3manufacturers in China registered for this device type
12catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Boston Medical Products, Inc., United States |
|---|---|
| FDA product code | LYA |
| Device type | Splint, Intranasal Septal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4780 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2022-09-29 |
| Record revised | 2022-08-30 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry; Special storage condition: Keep away from sunlight |
| Packaging | Carton of 10 |
| Sizes | Width 0.13 to 1.5 mm; length 51 mm; height 76 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60-313 | Width 0.50 mm | In distribution |
| 60-312 | Height 76 mm | In distribution |
| 60-310 | Height 76 mm | In distribution |
| 60-315 | Width 1.5 mm | In distribution |
| 60-312 | Height 76 mm | In distribution |
| 60-310 | Height 76 mm | In distribution |
| 60-311 | Width 0.50 mm | In distribution |
| 60-314 | Height 76 mm | In distribution |
| 60-311 | Width 0.50 mm | In distribution |
| 60-314 | Height 76 mm | In distribution |
| 60-315 | Width 1.5 mm | In distribution |
| 60-313 | Width 0.50 mm | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K972096 | 1997-07-15 |
| K972092 | 1997-07-08 |
| K972151 | 1997-07-07 |
| K972082 | 1997-07-03 |
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.