Arcadia™
63 catalogue numbers from 00884450547540, listed by Merit Medical Systems, Inc., United States, under Arthroscope. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
63catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (7), Jiangsu (6), Guangdong (5). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Jiangsu Shenli Medical Production Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
Showing 12 of 21. All 21 manufacturers in China registered for Arthroscope
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | HRX |
| Device type | Arthroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 888.1100 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2022-12-03 |
| Record revised | 2025-05-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 16, pack of 15 |
| Sizes | Needle gauge 10 G; balloon length 10 to 25 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450547540 | Balloon Length (mm)-20 mm | In distribution |
| G | Max Pressure (psi)-700 psi | In distribution |
| G | Max Volume (cc)-5 cc | In distribution |
| 00884450447253 | Gauge Size-10G | In distribution |
| D | Needle Gauge 10 G | In distribution |
| F | Balloon Length (mm)-10 mm | In distribution |
| F | Balloon Length (mm)-30 mm | In distribution |
| 00884450490914 | Gauge Size-10G | In distribution |
| 00884450447284 | Gauge Size-10G | In distribution |
| 00884450447130 | In distribution | |
| 00884450748978 | Balloon Length (mm)-10 mm | In distribution |
| D | Needle Gauge 10 G | In distribution |
| 00884450490884 | In distribution | |
| 00884450490761 | Max Pressure (psi)-700 psi | In distribution |
| 00884450447239 | Gauge Size-10G | In distribution |
| 00884450547519 | Gauge Size-10G | In distribution |
| F | Needle Gauge 10 G | In distribution |
| 00884450447109 | Gauge Size-10G | In distribution |
| F | In distribution | |
| 00884450547502 | Max Pressure (psi)-700 psi | In distribution |
| 00884450547557 | Gauge Size-10G | In distribution |
| G | Max Pressure (psi)-700 psi | In distribution |
| 00884450490853 | In distribution | |
| G | Balloon Length (mm)-20 mm | In distribution |
| D | Needle Gauge 10 G | In distribution |
| D | Needle Gauge 10 G | In distribution |
| 00884450447352 | Gauge Size-10G | In distribution |
| 00884450462478 | Max Volume (cc)-3 cc | In distribution |
| D | Balloon Length 10 mm | In distribution |
| 00884450490792 | Balloon Length (mm)-10 mm | In distribution |
| 00884450547359 | Gauge Size-10G | In distribution |
| F | Needle Gauge 10 G | In distribution |
| 00884450497524 | Max Pressure (psi)-700 psi | In distribution |
| 00884450447260 | Gauge Size-10G | In distribution |
| 00884450490891 | In distribution | |
| 00884450490860 | In distribution | |
| G | Balloon Length (mm)-10 mm | In distribution |
| 00884450547564 | Max Pressure (psi)-700 psi | In distribution |
| 00884450547533 | Gauge Size-10G | In distribution |
| F | Needle Gauge 10 G | In distribution |
| 00884450490846 | In distribution | |
| 00884450447161 | Gauge Size-10G | In distribution |
| 00884450447192 | Gauge Size-10G | In distribution |
| 00884450490907 | Max Volume (cc)-7 cc | In distribution |
| F | Needle Gauge 10 G | In distribution |
| G | Balloon Length (mm)-15 mm | In distribution |
| G | Balloon Length (mm)-15 mm | In distribution |
| 00884450490839 | Gauge Size-10G | In distribution |
| 00884450447116 | In distribution | |
| 00884450447291 | In distribution | |
| 00884450462539 | In distribution | |
| D | Needle Gauge 10 G | In distribution |
| F | Balloon Length (mm)-15 mm | In distribution |
| 00884450490877 | In distribution | |
| 00884450490808 | Max Pressure (psi)-700 psi | In distribution |
| 00884450547526 | Max Volume (cc)-4 cc | In distribution |
| 00884450447178 | In distribution | |
| 00884450447376 | Gauge Size-10G | In distribution |
| 00884450447222 | Gauge Size-10G | In distribution |
| 00884450447208 | In distribution | |
| 00884450447314 | Gauge Size-10G | In distribution |
| F | Gauge Size-10G | In distribution |
| 00884450447345 | Gauge Size-10G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 299 |
| Arthroscope | Karl Storz GmbH & Co. KG | 278 |
| Conmed/Linvatec | Provision | 265 |
| Arthroscope | Smith & Nephew, Inc. | 255 |
| Medline | Medline Industries, Inc. | 205 |
| Arthroscope | Sterilmed, Inc. | 184 |
| Sustainable Technologies | Provision | 150 |
| Medline Renewal | Medline Industries, Inc. | 123 |
| Stryker | Provision | 113 |
| Arthrex® | Arthrex, Inc. | 109 |
| Arthrex | Provision | 109 |
| Eberle | Eberle GmbH & Co. KG | 92 |
Showing 12 of 567. All products under Arthroscope
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191596 | 2019-10-09 |
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.