Crosstex International
(Sani-Roll 12"-200 M,1/CS)
5manufacturers in China registered for this device type
11catalogue 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 | Crosstex International, 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, Manufacturer |
| 510(k) | K941327 |
| Record published | 2016-11-11 |
| Record revised | 2025-07-25 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 12, case of 4, case of 2, case of 8, case of 6, case of 16 |
| Distribution end date | 2025-07-23 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SCT4200 | 200 | Withdrawn | |
| SCM | 200 | Withdrawn | |
| SCT6200 | 200 | Withdrawn | |
| SCT2200 | 200 | Withdrawn | |
| SCT6 | 100 | Withdrawn | |
| SCT8 | 100 | Withdrawn | |
| SCT3200 | 200 | Withdrawn | |
| SCT4 | 100 | Withdrawn | |
| SCT12200 | 200 | Withdrawn | |
| SCT3 | 100 | Withdrawn | |
| SCT2 | 100 | Withdrawn |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
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 |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | 510(k) number | 2022-05-25 | Class III | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | 1 case |
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.