Aptus
Instrument Case APTUS headedCCS 2.2, 3.0, 120 x 240 mm
5manufacturers in China registered for this device type
86catalogue numbers in this listing
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 | Medartis 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, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K202589 |
| Record published | 2020-11-14 |
| Record revised | 2023-04-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A-6603.121 | In distribution | |
| A-6603.043 | In distribution | |
| A-6706 | In distribution | |
| A-6603.421 | In distribution | |
| A-6603.431 | In distribution | |
| A-6603.411 | In distribution | |
| A-6603.131 | In distribution | |
| A-6603.761 | In distribution | |
| A-6603.743 | In distribution | |
| A-6603.561 | In distribution | |
| A-6603.471 | In distribution | |
| A-6603.131 | In distribution | |
| A-6603.742 | In distribution | |
| A-6603.061 | In distribution | |
| A-6603.581 | In distribution | |
| A-6603.481 | In distribution | |
| A-6603.111 | In distribution | |
| A-6603.442 | In distribution | |
| A-6610.50 | In distribution | |
| A-6603.543 | In distribution | |
| A-6603.571 | In distribution | |
| A-6610.50 | In distribution | |
| A-6603.043 | In distribution | |
| A-6603.581 | In distribution | |
| A-6603.743 | In distribution | |
| A-6603.461 | In distribution | |
| A-6603.441 | In distribution | |
| A-6603.141 | In distribution | |
| A-6603.581 | In distribution | |
| A-6603.071 | In distribution | |
| A-6603.071 | In distribution | |
| A-6603.542 | In distribution | |
| A-6603.431 | In distribution | |
| A-6603.443 | In distribution | |
| A-6603.061 | In distribution | |
| A-6603.081 | In distribution | |
| A-6603.742 | In distribution | |
| A-6603.121 | In distribution | |
| A-6603.781 | In distribution | |
| A-6603.543 | In distribution | |
| A-6603.111 | In distribution | |
| A-6603.443 | In distribution | |
| A-6603.061 | In distribution | |
| A-6705 | In distribution | |
| A-6603.761 | In distribution | |
| A-6603.542 | In distribution | |
| A-6603.742 | In distribution | |
| A-6603.761 | In distribution | |
| A-6603.461 | In distribution | |
| A-6603.471 | In distribution | |
| A-6603.481 | In distribution | |
| A-6603.471 | In distribution | |
| A-6603.461 | In distribution | |
| A-6603.441 | In distribution | |
| A-6603.571 | In distribution | |
| A-6710 | In distribution | |
| A-6603.561 | In distribution | |
| A-6603.111 | In distribution | |
| A-6603.543 | In distribution | |
| A-6603.561 | In distribution | |
| A-6603.081 | In distribution | |
| A-6603.781 | In distribution | |
| A-6603.743 | In distribution | |
| A-6709 | In distribution | |
| A-6603.542 | In distribution | |
| A-6603.121 | In distribution | |
| A-6603.141 | In distribution | |
| A-6603.441 | In distribution | |
| A-6603.141 | In distribution | |
| A-6603.443 | In distribution | |
| A-6603.481 | In distribution | |
| A-6603.131 | In distribution | |
| A-6610.50 | In distribution | |
| A-6603.571 | In distribution | |
| A-6708 | In distribution | |
| A-6603.431 | In distribution | |
| A-6603.421 | In distribution | |
| A-6603.442 | In distribution | |
| A-6603.081 | In distribution | |
| A-6603.781 | In distribution | |
| A-6603.411 | In distribution | |
| A-6603.043 | In distribution | |
| A-6603.071 | In distribution | |
| A-6603.442 | In distribution | |
| A-6603.411 | In distribution | |
| A-6603.421 | 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
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.