ONE Tray® Sealed Sterilization Container
(L) 23.142" x (H) 4.573" x (W) 11.616"
5manufacturers in China registered for this device type
24catalogue numbers in this listing
1recall
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 | Innovative Sterilization Techn, 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 | Manufacturer |
| 510(k) | K052567 |
| Record published | 2018-08-05 |
| Record revised | 2026-05-07 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CASE-1000-13 | In distribution | |
| M2404DT | In distribution | |
| ASSY-2135 | In distribution | |
| M2404 | In distribution | |
| ASSY-2415 | In distribution | |
| M2108DT | In distribution | |
| OTK-BOX50 | In distribution | |
| M2408 | In distribution | |
| ASSY-2425 | In distribution | |
| M2104 | In distribution | |
| M2406 | In distribution | |
| M2108 | In distribution | |
| OTTORANGE400 | In distribution | |
| M2106 | In distribution | |
| M2406DT | In distribution | |
| ASSY-2115 | In distribution | |
| OTTGREEN400 | In distribution | |
| ASSY-2125 | In distribution | |
| ASSY-2435 | In distribution | |
| M2104DT | In distribution | |
| M2408DT | In distribution | |
| M2106DT | In distribution | |
| ASSY-2145 | In distribution | |
| ASSY-2445 | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Innovative Sterilization Techn | 510(k) number | 2014-02-03 | Class II | Process control | The wrong sterilization time was on the label. The label lists Steam Gravity 10 – 34 minutes at 270 degrees F instead of Steam Gravity 17 – 34 minutes at 270 degrees F. | M2104 – 25 units; M2408 – 84 units | 2016-02-04 |
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.