Sonopet Iq Sterilization Tray
The Sonopet iQ Sterilization Tray holds and organizes reusable Stryker Sonopet iQ instruments during processing in a healthcare facility. Its perforated stainless steel base and lid allow…
The Sonopet iQ Sterilization Tray holds and organizes reusable Stryker Sonopet iQ instruments during processing in a healthcare facility. Its perforated stainless steel base and lid allow steam to reach the enclosed devices. Brackets hold the instruments in position, and latches secure the lid.
The tray is reusable and compatible with specified prevacuum steam cycles. It must be enclosed in a suitable cleared sterilization wrap or rigid container to maintain sterility after processing. The tray itself does not provide that sterile barrier and is supplied nonsterile.
Specified Load
Catalog 5500-800-278 accommodates one handpiece, one cleaning wire and one torque wrench, with a maximum tray weight of 6.85 lb. Retractable handles support carrying the loaded tray.
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), Guangdong (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 |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Lianyungang Anson Non-woven Product Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 13 |
| Medipack Medical Packaging MFG. Co. | Dongguan | Guangdong | Contract manufacturer | 5 |
| AR Medicom Inc., (Asia), Ltd. | Hongkong | Hong Kong | Exporter | 5 |
| Wipak Packaging (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Paragon Medical Inc., United States |
|---|---|
| FDA product code | KCT |
| Device type | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K190667 |
| Record published | 2019-06-28 |
| Record revised | 2022-09-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5500-800-278 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrusafe | Summit Medical LLC | 6,357 |
| V. Mueller | Steris Corporation | 1,080 |
| Ermis | Ermis MedTech | 597 |
| Bahadir USA | Bahadir USA LLC | 561 |
| Avalign | Avalign Technologies, Inc. | 447 |
| Sklar® | Sklar Corporation | 363 |
| HNM Medical | HNM Stainless, LLC. | 337 |
| Surgical Instrument | SIN Sistema DE Implante Nacional S.A | 295 |
| ReLine | Nuvasive, Inc. | 290 |
| Case Medical | Case Medical, Inc. | 289 |
| Millennium | Avalign Technologies, Inc. | 268 |
| V. Mueller | Carefusion 2200, Inc. | 174 |
Showing 12 of 599. All products under Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190667 | 2019-06-13 |
| K183701 | 2019-05-07 |
| K173615 | 2018-04-18 |
| K152951 | 2015-12-28 |
| K032119 | 2003-10-29 |
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.