Summit Medical
13 catalogue numbers from 11-STARTERRHINO, listed by Summit Medical LLC, United States, under Splint, Intranasal Septal. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
13catalogue 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 | Summit Medical LLC, United States |
|---|---|
| FDA product code | LYA |
| Device type | Splint, Intranasal Septal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4780 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-04-15 |
| Record revised | 2021-08-23 (version 3) |
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 |
| Packaging | Shelf box of 8, box, box of 5, shelf box of 50, shelf box of 4 |
| Distribution end date | 2023-06-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11-STARTERRHINO | In distribution | |
| SP-79400 | In distribution | |
| 11S-S1000-08AS | In distribution | |
| 11S-S0500-08AS | In distribution | |
| 11W-W0500-08AS | In distribution | |
| 11S-S0300-08AS | In distribution | |
| 11W-W1000-08AS | In distribution | |
| SP-79300 | In distribution | |
| 11W-W0800-08AS | In distribution | |
| 11S-S0800-08AS | In distribution | |
| 11W-W0300-08AS | In distribution | |
| 11S-S0800-4PAS | In distribution | |
| 11S-S0800-08AS | Withdrawn |
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
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.