Pro-Lite
The PRO-LITE Sterilization Tray, 25-inch x 11.75-inch x 4.5-inch is used with the V-PRO Low Temperature Sterilization Systems and STERRAD NX, 100S and 100NX sterilizers.
5manufacturers in China registered for this device type
35catalogue numbers in this listing
11510(k) clearances naming this product code
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 | Steris Corporation, 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, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2018-02-01 |
| Record revised | 2024-10-21 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
| Sizes | Width 5 to 14 in; length 12 to 27 in |
| Distribution end date | 2025-12-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VP0074 | Length 13 in | In distribution |
| VP0076 | Width 8 in | In distribution |
| VP0077 | Width 12 in | In distribution |
| VP0046 | In distribution | |
| VP0047 | In distribution | |
| VP0078 | Length 25 in | In distribution |
| VP0052 | In distribution | |
| VP0072 | Length 19 in | In distribution |
| VP0073 | Width 5 in | In distribution |
| VP0071 | Width 5 in | In distribution |
| VP0051 | In distribution | |
| VP0050 | In distribution | |
| VP0049 | In distribution | |
| VP0045 | In distribution | |
| VP0075 | Length 19 in | In distribution |
| VP0079 | Width 14 in | In distribution |
| VP0048 | In distribution | |
| VP0053 | In distribution | |
| VP0047 | Withdrawn | |
| VP0076 | Width 8 in | Withdrawn |
| VP0050 | Withdrawn | |
| VP0045 | Withdrawn | |
| VP0051 | Withdrawn | |
| VP0072 | Width 5 in | Withdrawn |
| VP0074 | Width 8 in | Withdrawn |
| VP0053 | Withdrawn | |
| VP0079 | Length 25 in | Withdrawn |
| VP0049 | Withdrawn | |
| VP0048 | Withdrawn | |
| VP0046 | Withdrawn | |
| VP0077 | Width 12 in | Withdrawn |
| VP0075 | Width 8 in | Withdrawn |
| VP0052 | Withdrawn | |
| VP0078 | Width 12 in | Withdrawn |
| VP0071 | Width 5 in | Withdrawn |
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 |
|---|---|
| K231501 | 2023-08-07 |
| K183402 | 2019-03-01 |
| K183301 | 2019-01-03 |
| K172755 | 2018-02-09 |
| K160912 | 2016-10-07 |
| K140494 | 2014-07-25 |
| K103226 | 2011-02-18 |
| K092745 | 2010-11-19 |
| K090371 | 2009-05-01 |
| K070765 | 2007-10-12 |
| K070769 | 2007-10-05 |
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.