Ultracell®
***NON-Sterile*** Anatomical Nasal Pack W/Tube, 8CM W/String 15MM Thick, NO VAC Foil (500/SP)
6manufacturers in China registered for this device type
51catalogue 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 | Beaver-Visitec International, Ltd, United Kingdom |
|---|---|
| FDA product code | EMX |
| Device type | Balloon, Epistaxis |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4100 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K924542 |
| Record published | 2024-06-27 |
| Record revised | 2023-10-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: Store in a dry place. |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SS10150-C | In distribution | ||
| 10110-C | In distribution | ||
| 10100-C | In distribution | ||
| NS10100-C | In distribution | ||
| SS10140-C | In distribution | ||
| 20212-C | In distribution | ||
| NS10111-C | In distribution | ||
| NS10140-C | In distribution | ||
| SS10110-CTN | In distribution | ||
| SS10111-C | In distribution | ||
| SS10115-C | In distribution | ||
| SS10100-C | In distribution | ||
| NSNETSTRIP35 | 300 | In distribution | |
| 10115-C | In distribution | ||
| NS10120-CTN | In distribution | ||
| SS50105-C | In distribution | ||
| SS10116-L | In distribution | ||
| NSNETSTRIP30 | 300 | In distribution | |
| NS20210-C | In distribution | ||
| NS10110-CTN | In distribution | ||
| 20202-C | In distribution | ||
| NSNETSTRIP18 | 500 | In distribution | |
| NS10150-C | In distribution | ||
| NS10100-CTN | In distribution | ||
| 10140-C | In distribution | ||
| 10120-C | In distribution | ||
| SS10110-C | In distribution | ||
| SS20200-C | In distribution | ||
| SS10116-C | In distribution | ||
| 20211-C | In distribution | ||
| SS20210-C | In distribution | ||
| SS10111-L | In distribution | ||
| SS10101-C | In distribution | ||
| SS10145-C | In distribution | ||
| 10146-C | In distribution | ||
| SS10111-CT | In distribution | ||
| SS10141-C | In distribution | ||
| NS10110-C | In distribution | ||
| SS20201-C | In distribution | ||
| SS50110 | In distribution | ||
| NSNETSTRIP29 | 300 | In distribution | |
| 20210-C | In distribution | ||
| SS10125-C | In distribution | ||
| SS50111-C | In distribution | ||
| NSNETSTRIP19 | 500 | In distribution | |
| NSNETSTRIP28 | 300 | In distribution | |
| 10150-C | In distribution | ||
| NSNETSTRIP26 | 500 | In distribution | |
| SS10141-L | In distribution | ||
| SS10105-C | In distribution | ||
| 10160-C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Osseous | EON Meditech PVT. Ltd. | 123 |
| 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.