Steriking®
95 catalogue numbers from R44, listed by Wipak OY, Finland, under Sterilization Wrap Containers, Trays, Cassettes & Other Accessories. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
95catalogue 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 | Wipak OY, Finland |
|---|---|
| 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) | K953776 |
| Record published | 2016-09-14 |
| Record revised | 2019-11-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Ethylene Oxide |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 5, pack of 3, pack of 6 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| R44 | In distribution | ||
| LTS1025NI | 200 | In distribution | |
| LTSS6NI | 200 | In distribution | |
| LTSS1NI | 200 | In distribution | |
| S7 | 600 | In distribution | |
| S23 | 1,800 | In distribution | |
| S10 | 600 | In distribution | |
| B31 | 500 | In distribution | |
| B30 | 500 | In distribution | |
| B36 | 250 | In distribution | |
| S29 | 600 | In distribution | |
| LTR44NI | In distribution | ||
| B37 | 250 | In distribution | |
| R39 | 5 | In distribution | |
| LTS7520 | 200 | In distribution | |
| S12 | 1,800 | In distribution | |
| R40 | 4 | In distribution | |
| R40/31 | 10 | In distribution | |
| LTS1025 | 200 | In distribution | |
| RB52 | 2 | In distribution | |
| RB51 | 3 | In distribution | |
| S34 | 1,200 | In distribution | |
| S14 | 600 | In distribution | |
| LTSS7 | 200 | In distribution | |
| S16 | 1,200 | In distribution | |
| S13 | 1,200 | In distribution | |
| S20 | 1,800 | In distribution | |
| LTS2550NI | 200 | In distribution | |
| LTR41NI | 2 | In distribution | |
| R39/31 | 10 | In distribution | |
| S6 | 1,800 | In distribution | |
| LTS2038 | 200 | In distribution | |
| LTSS7NI | 200 | In distribution | |
| B35 | 500 | In distribution | |
| LTR44 | In distribution | ||
| S30 | 600 | In distribution | |
| LTS1530 | 200 | In distribution | |
| LTSS6 | 200 | In distribution | |
| S4 | 3,600 | In distribution | |
| R41 | 3 | In distribution | |
| LTR43ANI | In distribution | ||
| S15 | 1,200 | In distribution | |
| S24 | 2,400 | In distribution | |
| RB54 | In distribution | ||
| R42/31 | 16 | In distribution | |
| R42 | 2 | In distribution | |
| S25 | 2,400 | In distribution | |
| RB53 | In distribution | ||
| S5 | 3,000 | In distribution | |
| S7A | 1,000 | In distribution | |
| LTSS5ANI | 200 | In distribution | |
| LTSS4A | 200 | In distribution | |
| LTSS2 | 200 | In distribution | |
| S33 | 1,000 | In distribution | |
| R41/31 | 10 | In distribution | |
| LTR43 | In distribution | ||
| S27 | 1,200 | In distribution | |
| R43 | In distribution | ||
| LTSS2NI | 200 | In distribution | |
| S19 | 1,200 | In distribution | |
| LTR42 | In distribution | ||
| LTR41 | 2 | In distribution | |
| LTR40NI | 2 | In distribution | |
| S26 | 2,400 | In distribution | |
| LTR40 | 2 | In distribution | |
| LTR45NI | In distribution | ||
| LTS7520NI | 200 | In distribution | |
| RB56 | In distribution | ||
| S32 | 500 | In distribution | |
| S31 | 500 | In distribution | |
| LTS2550 | 200 | In distribution | |
| LTS2538 | 200 | In distribution | |
| RB55 | In distribution | ||
| S2 | 2,400 | In distribution | |
| LTSS4 | 200 | In distribution | |
| S3 | 1,800 | In distribution | |
| S8 | 1,200 | In distribution | |
| R45/31 | 6 | In distribution | |
| LTR43 NI | In distribution | ||
| B34 | 250 | In distribution | |
| S28 | 1,200 | In distribution | |
| LTSS5A | 200 | In distribution | |
| R44/31 | 6 | In distribution | |
| RB57 | In distribution | ||
| LTSS4NI | 200 | In distribution | |
| S21 | 600 | In distribution | |
| R45 | In distribution | ||
| LTS1530NI | 200 | In distribution | |
| LTR42NI | In distribution | ||
| LTSS4ANI | 200 | In distribution | |
| R43/31 | 6 | In distribution | |
| LTSS1 | 200 | In distribution | |
| LTR45 | In distribution | ||
| RB50 | 4 | In distribution | |
| LTR43A | 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.