Osseous
Epistaxis Balloon Catheter is designed for fast control of intra-nasal bleeding and patient comfort. Ideal for nasal packing for Septoplastly, Rhinoplastly and Intra-nasal surgical…
Epistaxis Balloon Catheter is designed for fast control of intra-nasal bleeding and patient comfort. Ideal for nasal packing for Septoplastly, Rhinoplastly and Intra-nasal surgical procedure. Inflatable flexible balloon provides direct uniform pressure. Beveled posterior tip & soft silicone construction allow for easy placement & prevents adhesion for easy removal. Airway channel design allows nasal breathing.
6manufacturers in China registered for this device type
123catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), Tianjin (1), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Guangdong Tidakang Medical Technology Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 12 |
| Guangzhou Kaiheng K&S Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | EON Meditech PVT. Ltd., India |
|---|---|
| FDA product code | EMX |
| Device type | Balloon, Epistaxis |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4100 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-06-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | 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 20, laminated box, laminated box of 2, pack of 10, laminated box of 5 |
| Sizes | Length 1.5 to 10 cm; height 1 to 1.5 cm; width 0.6 to 3 cm; balloon diameter 22 to 34 mm; balloon length 22 to 40 mm; catheter working length 135 to 200 mm; weight 2.5 g |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E7184-O | Length 1.5 cm | In distribution |
| E7190-SC | Length 8 cm | In distribution |
| E7187-OC | Length 10 cm | In distribution |
| E7179 | Length 4.5 cm | In distribution |
| E7186-L | Length 10 cm | In distribution |
| ENOZ-OK-10 | Length 4.5 cm | In distribution |
| E7185-C | Length 10.0 cm | In distribution |
| E7184 | Length 1.5 cm | In distribution |
| E7176-OC | Length 4.5 cm | In distribution |
| E7188-OC | Length 8 cm | In distribution |
| E7178 | Length 4.5 cm | In distribution |
| ENOZ-CL-10 | Length 4.5 cm | In distribution |
| E7192-C | Length 3.5 cm | In distribution |
| E7177 | Length 4.5 cm | In distribution |
| ENOZ-OA-5 | Length 4.5 cm | In distribution |
| E7183-O | Length 8.0 cm | In distribution |
| E7178-C | Length 4.5 cm | In distribution |
| E7182-C | Length 8.0 cm | In distribution |
| E7191 | Length 3.5 cm | In distribution |
| E7181 | Length 8 cm | In distribution |
| E7185-L | Length 10 cm | In distribution |
| E31030 | Catheter Working Length 135 mm | In distribution |
| E7189-O | Length 8.0 cm | In distribution |
| E7193-L | Length 5.5 cm | In distribution |
| E7185-O | Length 10.0 cm | In distribution |
| E7187-L | Length 10 cm | In distribution |
| E7177-OC | Length 4.5 cm | In distribution |
| E7182-OC | Length 8.0 cm | In distribution |
| E7190-OC | Length 8 cm | In distribution |
| E7193-O | Length 5.5 cm | In distribution |
| E7189-L | Length 8 cm | In distribution |
| E7177-O | Length 4.5 cm | In distribution |
| E7186 | Length 10 cm | In distribution |
| E7179-L | Length 4.5 cm | In distribution |
| E7180-O | Length 8.0 cm | In distribution |
| E7190-C | Length 8.0 cm | In distribution |
| E7179-OC | Length 8 cm | In distribution |
| E7183-C | Length 8.0 cm | In distribution |
| E7183-OC | Length 8.0 cm | In distribution |
| E7190-O | Length 8.0 cm | In distribution |
| ENOZ-OL-2 | Length 4.5 cm | In distribution |
| E7183-SC | Length 8.0 cm | In distribution |
| E7180 | Length 8.0 cm | In distribution |
| E7185-OC | Length 10 cm | In distribution |
| E7190-L | Length 8 cm | In distribution |
| ENOZ-OA-10 | Length 4.5 cm | In distribution |
| E7188-O | Length 8.0 cm | In distribution |
| E7184-SC | Length 10 cm | In distribution |
| E7186-SC | Length 10 cm | In distribution |
| E7181-SC | Length 8.0 cm | In distribution |
| E7187-C | Length 10.0 cm | In distribution |
| E7186-C | Length 10.0 cm | In distribution |
| E7188 | Length 8.0 cm | In distribution |
| E7181-OC | Length 8.0 cm | In distribution |
| E7193-C | Length 5.5 cm | In distribution |
| E7193-SC | Length 5.5 cm | In distribution |
| E7191-SC | Length 3.5 cm | In distribution |
| E31010 | Catheter Working Length 200 mm | In distribution |
| E7176-SC | Length 4.5 cm | In distribution |
| E7189-C | Length 8.0 cm | In distribution |
| E7176-C | Length 4.5 cm | In distribution |
| E7177-SC | Length 4.5 cm | In distribution |
| E7178-O | Length 4.5 cm | In distribution |
| ENOZ-CK-2 | Length 4.5 cm | In distribution |
| E7188-SC | Length 8 cm | In distribution |
| E7177-C | Length 4.5 cm | In distribution |
| ENOZ-CK-10 | Length 4.5 cm | In distribution |
| E7186-O | Length 10.0 cm | In distribution |
| ENOZ-CA-10 | Length 4.5 cm | In distribution |
| E7188-L | Length 8 cm | In distribution |
| E7181-O | Length 8.0 cm | In distribution |
| E7184-OC | Length 10 cm | In distribution |
| E7177-L | Length 4.5 cm | In distribution |
| E7178-SC | Length 4.5 cm | In distribution |
| E7184-C | Length 10.0 cm | In distribution |
| E31031 | Catheter Working Length 160 mm | In distribution |
| E7192 | Length 3.5 cm | In distribution |
| E7176-O | Length 4.5 cm | In distribution |
| E7181-L | Length 8.0 cm | In distribution |
| E7185-SC | Length 10 cm | In distribution |
| E7179-C | Length 4.5 cm | In distribution |
| E7192-O | Length 3.5 cm | In distribution |
| E7179-SC | Length 4.5 cm | In distribution |
| E7190 | Length 8 cm | In distribution |
| E7192-L | Length 3.5 cm | In distribution |
| E7176-L | Length 4.5 cm | In distribution |
| ENOZ-OA-2 | Length 4.5 cm | In distribution |
| E7193 | Length 5.5 cm | In distribution |
| E7180-L | Length 8.0 cm | In distribution |
| E7187-SC | Length 10 cm | In distribution |
| ENOZ-OL-10 | Length 4.5 cm | In distribution |
| E7191-C | Length 3.5 cm | In distribution |
| E7188-C | Length 8.0 cm | In distribution |
| E7180-OC | Length 8.0 cm | In distribution |
| E7187 | Length 10 cm | In distribution |
| E7192-OC | Length 3.5 cm | In distribution |
| E7187-O | Length 10.0 cm | In distribution |
| E7178-OC | Length 4.5 cm | In distribution |
| E7182 | Length 8 cm | In distribution |
| E7179-O | Length 4.5 cm | In distribution |
| E7186-OC | Length 10 cm | In distribution |
| E7185 | Length 10 cm | In distribution |
| ENOZ-OK-2 | Length 4.5 cm | In distribution |
| E7192-SC | Length 3.5 cm | In distribution |
| E7176 | Length 4.5 cm | In distribution |
| E7182-L | Length 8.0 cm | In distribution |
| E7189-SC | Length 8 cm | In distribution |
| E7183 | Length 8 cm | In distribution |
| E7189 | Length 8 cm | In distribution |
| ENOZ-CA-2 | Length 4.5 cm | In distribution |
| E7189-OC | Length 8 cm | In distribution |
| E7182-SC | Length 8.0 cm | In distribution |
| E7178-L | Length 4.5 cm | In distribution |
| E7193-OC | Length 5.5 cm | In distribution |
| E7181-C | Length 8.0 cm | In distribution |
| E7191-OC | Length 3.5 cm | In distribution |
| E7184-L | Length 10 cm | In distribution |
| E7180-SC | Length 8.0 cm | In distribution |
| E7183-L | Length 8 cm | In distribution |
| E7180-C | Length 8.0 cm | In distribution |
| E7182-O | Length 8.0 cm | In distribution |
| E7191-L | Length 3.5 cm | In distribution |
| E7191-O | Length 3.5 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ultracell® | Beaver-Visitec International, Ltd | 51 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 50 |
| Fabco | First AID Bandage Co Inc | 17 |
| DeRoyal | Deroyal Industries, Inc. | 14 |
| Epistax Balloon Catheter | Summit Medical LLC | 12 |
| Rapid Rhino | Smith & Nephew, Inc. | 12 |
| Netcell | Network Medical Products, Ltd. | 8 |
| Rhinocell® Nasal Packing | Boston Medical Products, Inc. | 8 |
| Rhino Rocket | Gyrus Acmi, Inc. | 4 |
| Epi-Max™ Epistaxis Procedure Pack | Boston Medical Products, Inc. | 4 |
| Nose It All | Product Motif Inc. | 4 |
| Merogel Nasal Dressing/Sinus Stent &Otologic Packing 4x4cm | Anika Therapeutics, Inc. | 4 |
Showing 12 of 47. All products under Balloon, Epistaxis
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.