Gsource
Instrument Containter Bottom, Mini, 310x131x56mm outside, perforated, alum include 01.8020PI insrt
5manufacturers in China registered for this device type
42catalogue 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 | Gsource, LLC., 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, Reprocessor, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K123234 |
| Record published | 2022-05-27 |
| Record revised | 2023-04-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| gS 98.9204 | In distribution | |
| gS 98.9000 | In distribution | |
| gS 98.9342 | In distribution | |
| gS 98.9131 | In distribution | |
| gS 98.9203 | In distribution | |
| gS 98.9341 | In distribution | |
| gS 98.9501 | In distribution | |
| gS 98.9605 | In distribution | |
| gS 98.9135 | In distribution | |
| gS 98.9910 | In distribution | |
| gS 98.9134 | In distribution | |
| gS 98.9001 | In distribution | |
| gS 98.9003 | In distribution | |
| gS 98.9206 | In distribution | |
| gS 98.9343 | In distribution | |
| gS 98.9205 | In distribution | |
| gS 98.9900 | In distribution | |
| gS 98.9532 | In distribution | |
| gS 98.9346 | In distribution | |
| gS 98.9133 | In distribution | |
| gS 98.9355 | In distribution | |
| gS 98.9345 | In distribution | |
| gS 98.9353 | In distribution | |
| gS 98.9800 | In distribution | |
| gS 98.9920 | In distribution | |
| gS 98.9700 | In distribution | |
| gS 98.9002 | In distribution | |
| gS 98.9533 | In distribution | |
| gS 98.9191 | In distribution | |
| gS 98.9354 | In distribution | |
| gS 98.9202 | In distribution | |
| gS 98.9136 | In distribution | |
| gS 98.9356 | In distribution | |
| gS 98.9504 | In distribution | |
| gS 98.9344 | In distribution | |
| gS 98.9503 | In distribution | |
| gS 98.9192 | In distribution | |
| gS 98.9502 | In distribution | |
| gS 98.9352 | In distribution | |
| gS 98.9132 | In distribution | |
| gS 98.9351 | In distribution | |
| gS 98.9201 | 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 |
|---|---|---|---|---|---|---|
| Jewel Precision Sheet Metal & Machining, Inc. | 510(k) number | 2025-05-22 | Class II | No Marketing Application | The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life. | 11 units |
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.