Straumann BLX Surgical Cassette
The Straumann BLX Surgical Cassette organizes and encloses medical instruments between surgical uses. Healthcare facilities use it for cleaning, sterilization, transport and storage of the…
The Straumann BLX Surgical Cassette organizes and encloses medical instruments between surgical uses. Healthcare facilities use it for cleaning, sterilization, transport and storage of the instruments used with the BLX dental implant workflow.
The container has a lid, base and tray made from polyphenylsulfone. Silicone rubber grommets hold instruments in the base and tray. Printed markings identify instrument positions and the surgical workflow, helping arrange the contents within the cassette.
Listed Item
BLX Surgical Cassette, Guided
Sterilization Requirements
The cassette does not maintain sterility by itself and must be used with a validated sterilization wrap. Its validated maximum load is 300 grams, including cassette and instruments. The specified prevacuum steam cycle uses 132 degrees Celsius for four minutes, followed by 20 minutes of drying.
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 | Institut Straumann AG, Switzerland |
|---|---|
| FDA product code | KCT |
| Device type | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K180791 |
| Record published | 2019-10-31 |
| Record revised | 2023-09-19 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | 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 |
|---|---|
| K260726 | 2026-06-03 |
| K191522 | 2019-12-03 |
| K180791 | 2018-06-21 |
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.