Counter, Sponge, Surgical
Surgical Tablet Docking Station Wall Mount
17manufacturers in China registered for this device type
11catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (5), Guangdong (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Guangdong Shunde LQX Health Technology Inc. | Foshan | Guangdong | Contract manufacturer | 24 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Shanghai Leyi Plastic Products Co Ltd | Shanghai | Shanghai | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Shanghai Dynamic Medical Supplies Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 37 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Mobility Source Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 26 |
Showing 12 of 17. All 17 manufacturers in China registered for Counter, Sponge, Surgical
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | LWH |
| Device type | Counter, Sponge, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 880.2740 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-04-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment humidity 10 to 75 % RH; Storage environment temperature -20 to 40 °C |
| Packaging | Pack of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0794001030 | In distribution | |
| 0794001080 | In distribution | |
| 0794001060 | In distribution | |
| 0794001020 | In distribution | |
| 0794001070 | In distribution | |
| 0794001010 | In distribution | |
| 0694097001 | In distribution | |
| 0694097020 | In distribution | |
| 0794001050 | In distribution | |
| 0694097000 | In distribution | |
| 0794001040 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SurgiCount | Stryker GmbH | 20 |
| ORLocate | Steris Corporation | 19 |
| Situate | Covidien LP | 12 |
| Medline | Medline Industries, Inc. | 3 |
| Devon | Cardinal Health | 3 |
| AMD-Ritmed | AMD Medicom Inc. | 3 |
| HCS | Dyad Medical Sourcing, LLC | 2 |
| MediChoice | Owens & Minor Distribution, Inc. | 2 |
| Medical Action Industries | Medical Action Industries, Inc. | 2 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 1 |
| Novaplus® | Medical Action Industries, Inc. | 1 |
| HCS | Concordance Healthcare Solutions LLC | 1 |
Showing 12 of 14. All products under Counter, Sponge, Surgical
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-06-15 | Class II | Under Investigation by firm | When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this err | 44 units | 2024-04-05 |
| 2016-03-21 | Class II | Software design | The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2). Also, the SurgiCounter scanner software version number is n | 286 | 2016-09-06 |
| 2013-06-16 | Class II | Device Design | Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure. | 3625 | 2015-08-20 |
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.