ORLocate
ORLocate Sponge Solution is an innovative counting and locating technology that enhances patient safety and reduces time spent counting and searching for sponges in the operating room.
17manufacturers in China registered for this device type
19catalogue numbers in this listing
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 | Steris Corporation, United States |
|---|---|
| FDA product code | LWH |
| Device type | Counter, Sponge, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 880.2740 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K100551 |
| Record published | 2025-04-17 |
| Record revised | 2025-04-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Distribution end date | 2025-04-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ORLocate Components Pack | In distribution | |
| ORLocate Locator | In distribution | |
| ORLocate Roll Stand | In distribution | |
| ORLocate Sponge Solution | In distribution | |
| ORLocate Tablet | In distribution | |
| ORLocate HoveRead | In distribution | |
| ORLocate Reader Box LAN | In distribution | |
| ORLocate Reader Box | In distribution | |
| ORLocate HoveRead | Withdrawn | |
| ORLocate Reader Box | Withdrawn | |
| ORLocate HoveRead | Withdrawn | |
| ORLocate Reader Box | Withdrawn | |
| ORLocate Sponge Solution | Withdrawn | |
| ORLocate Reader Box LAN | Withdrawn | |
| ORLocate Locator | Withdrawn | |
| ORLocate Roll Stand | Withdrawn | |
| ORLocate Locator | Withdrawn | |
| ORLocate Tablet | Withdrawn | |
| ORLocate Components Pack | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SurgiCount | Stryker GmbH | 20 |
| Situate | Covidien LP | 12 |
| Counter, Sponge, Surgical | Stryker GmbH | 11 |
| 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
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.