Halyard
STERISYSTEM® Accessories DRY-BASE® Stainless Steel Lid for Instrument Tray - ISO 1/1
5manufacturers in China registered for this device type
25catalogue numbers in this listing
1510(k) clearance
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 | O&M Halyard, 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 | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K203177 |
| Record published | 2022-05-18 |
| Record revised | 2019-11-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| Packaging | Case of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 47917 | In distribution | ||
| 47916 | In distribution | ||
| 68509 | 250 | In distribution | |
| 47430 | 6 | In distribution | |
| 47428 | 6 | In distribution | |
| 47922 | In distribution | ||
| 47429 | 6 | In distribution | |
| 47414 | 12 | In distribution | |
| 47419 | 12 | In distribution | |
| 47918 | In distribution | ||
| 47426 | 6 | In distribution | |
| 47418 | 6 | In distribution | |
| 47416 | 6 | In distribution | |
| 47915 | In distribution | ||
| 47425 | 12 | In distribution | |
| 47914 | In distribution | ||
| 68507 | 250 | In distribution | |
| 47442 | 6 | In distribution | |
| 47432 | 6 | In distribution | |
| 47431 | 6 | In distribution | |
| 47920 | In distribution | ||
| 47919 | In distribution | ||
| 47921 | In distribution | ||
| 47417 | 6 | In distribution | |
| 47413 | 12 | 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 |
|---|---|
| K203177 | 2022-01-02 |
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.