Invotec Ultra-Stat
Ultra Stat Epistaxis Nasal Balloon, Silicone
6manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
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 | Invotec International, Inc., United States |
|---|---|
| FDA product code | EMX |
| Device type | Balloon, Epistaxis |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4100 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20-10700 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Osseous | EON Meditech PVT. Ltd. | 123 |
| 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 |
Showing 12 of 47. All products under Balloon, Epistaxis
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K971000 | 1997-05-14 |
| K901310 | 1990-06-14 |
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.