Situate
Body Scanner Lite For use with the Situate Detection Console 200E and Console 200X
17manufacturers in China registered for this device type
12catalogue 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 | Covidien LP, United States |
|---|---|
| FDA product code | LWH |
| Device type | Counter, Sponge, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 880.2740 |
| Premarket notification | Exempt |
| Record published | 2018-10-13 |
| Record revised | 2025-06-24 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature 50 to 104 °F; Handling environment humidity 15 to 90 % RH; Storage environment humidity 20 to 90 % RH; Handling environment temperature -22 to 140 °F; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| Packaging | Case of 5 |
| Distribution end date | 2026-02-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-0031 | In distribution | |
| 01-0034 | In distribution | |
| 01-0043R | In distribution | |
| 01-0043 | In distribution | |
| 01-0034V02-RFB | In distribution | |
| 01-0046 | In distribution | |
| 01-0035 | In distribution | |
| 01-0030R | In distribution | |
| 01-0044 | In distribution | |
| 01-0034R | In distribution | |
| 01-0043V02-RFB | In distribution | |
| 01-0043RS | Current,100-240,V; | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SurgiCount | Stryker GmbH | 20 |
| ORLocate | Steris Corporation | 19 |
| 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.