Elite
ELITE Flat Bottom Chest Roll 51X15X10 is used for prone and lateral postures and may be used in conjunction with the Prone Positioner (BF485) and Prone Headrest (BF464 large/BF465 medium).
4manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Hebei (3), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shijiazhuang Aofeite Medical Device Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 28 |
| Hebei Webian Medical Instrument Trading Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 14 |
| HI-Life Technology (Hebei) Co., Ltd. | Bazhou | Hebei | Manufacturer | 11 |
Record
| Listed by | Steris Corporation, United States |
|---|---|
| FDA product code | LWG |
| Device type | Surgical Table Cushion |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4950 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-01 |
| Record revised | 2025-03-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature -18 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BF464 | In distribution | |
| BF466 | In distribution | |
| BF465 | In distribution | |
| BF484 | In distribution | |
| BF483 | In distribution | |
| BF467 | In distribution | |
| BF485 | In distribution | |
| BF482 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Birkova | Steris Corporation | 455 |
| Rayshield | Aadco Medical, Inc. | 381 |
| Coulmed | Coulmed Products Group LLC | 343 |
| Skytron | Skytron, LLC | 307 |
| Aadco | Aadco Medical, Inc. | 267 |
| Surgical Table Cushion | Steris Corporation | 265 |
| XcelGel | Polymer Concepts, Inc. | 211 |
| Tablepad | Burlington Medical, LLC | 145 |
| Surgical Table Cushion | David Scott Company. | 107 |
| Prime Medical LLC | Prime Medical, Inc. | 81 |
| C-Matt | Casco Manufacturing Solutions, Inc. | 68 |
| Operon | Stryker Communications, Inc. | 31 |
Showing 12 of 369. All products under Surgical Table Cushion
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.