Gyrus Acmi
Sterile Expandacell Sponge, Rhino Rocket Wideline Nasal Pack, X-Large (polyvinyl alcohol sponge) (6/PK)
6manufacturers in China registered for this device type
50catalogue 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 | Gyrus Acmi, Inc., United States |
|---|---|
| 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, Exporter |
| 510(k) | K983276 |
| Record published | 2018-09-13 |
| Record revised | 2026-06-04 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10, pack of 6 |
| Distribution end date | 2026-03-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7089-0832 | In distribution | |
| 7089-0857 | In distribution | |
| 70890728 | In distribution | |
| 7089-0834 | In distribution | |
| 7089-0830 | In distribution | |
| 7089-0840 | In distribution | |
| 7089-0856 | In distribution | |
| 70890738 | Withdrawn | |
| 70890740 | Withdrawn | |
| 7089-0855 | Withdrawn | |
| 890922 | Withdrawn | |
| 70890735 | Withdrawn | |
| 7089-0838 | Withdrawn | |
| 7089-0846 | Withdrawn | |
| 7089-0839 | Withdrawn | |
| 70890743 | Withdrawn | |
| 890923 | Withdrawn | |
| 7089-0852 | Withdrawn | |
| 70890737 | Withdrawn | |
| 70890751 | Withdrawn | |
| 70890757 | Withdrawn | |
| 7089-0849 | Withdrawn | |
| 7089-0848 | Withdrawn | |
| 70890739 | Withdrawn | |
| 70890752 | Withdrawn | |
| 7089-0853 | Withdrawn | |
| 7089-0843 | Withdrawn | |
| 7089-0836 | Withdrawn | |
| 70890929 | Withdrawn | |
| 890912 | Withdrawn | |
| 7089-0833 | Withdrawn | |
| 70890741 | Withdrawn | |
| 7089-0842 | Withdrawn | |
| 70890754 | Withdrawn | |
| 7089-0831 | Withdrawn | |
| 7089-0854 | Withdrawn | |
| 7089-0841 | Withdrawn | |
| 70890733 | Withdrawn | |
| 70890750 | Withdrawn | |
| 7089-0844 | Withdrawn | |
| 7089-0850 | Withdrawn | |
| 7089-0837 | Withdrawn | |
| 7089-0851 | Withdrawn | |
| 7089-0835 | Withdrawn | |
| 70890753 | Withdrawn | |
| 7089-0845 | Withdrawn | |
| 70890742 | Withdrawn | |
| 890911 | Withdrawn | |
| 7089-0847 | Withdrawn | |
| 70890755 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Osseous | EON Meditech PVT. Ltd. | 123 |
| Ultracell® | Beaver-Visitec International, Ltd | 51 |
| 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.