Harmonic
Harmonic Sterilization Tray
36manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Guangdong (9), Jiangsu (8), Zhejiang (5). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 29 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| JIE GAO Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Guangdong Huilin Packaging Technology Group Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 3 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
Showing 12 of 36. All 36 manufacturers in China registered for Tray, Surgical
Record
| Listed by | Ethicon Endo-Surgery, Inc., United States |
|---|---|
| FDA product code | LRP |
| Device type | Tray, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-07-15 |
| Record revised | 2023-04-04 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 4, case of 6 |
| Distribution end date | 2022-03-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HST01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 12,037 |
| Centurion | Centurion Medical Products Corporation | 2,023 |
| Medline | Medline Industries, Inc. | 773 |
| PST Trays | Ambler Surgical, LLC | 128 |
| AngioSystems Tray | Angiosystems, Inc. | 126 |
| Tray, Surgical | Wright Medical Technology, Inc. | 123 |
| Medin Corporation | Ambler Surgical, LLC | 96 |
| Aligned Medical Solutions | Aligned Medical Solutions | 92 |
| Stradis | Stradis Healthcare | 91 |
| Cortera Spinal Fixation System | Xtant Medical Holdings, Inc. | 90 |
| SteriBest | Surgical Products Corp. | 84 |
| Elmed | Elmed, Inc. | 79 |
Showing 12 of 808. All products under Tray, Surgical
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-03-27 | Not classified | Other | The firm initiated this second subsequent recall because the affected devices can remain closed and clamped on tissue during surgical procedures due to the fact that the mechanism which connects the articulation joint to the device shaft i | 135 kits | 2013-02-15 |
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.