Gyrus Acmi
Small Disposable "donut" Head Rest Note: IF Using This Product IN Sterile Field, Drape Appropiately (12/PK)
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yearstar Healthcare Technology Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 43 |
| Bestway Plastic And Metal Products Ltd. | Dongguan | Guangdong | Manufacturer | 13 |
Record
| Listed by | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | EPW |
| Device type | Support, Head, Surgical, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4950 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-10-24 |
| Record revised | 2024-12-31 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 290135 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bio-Flek | Medtronic Xomed, Inc. | 4 |
| Solution bowl | Spiggle & Theis Medizintechnik Gmbh | 3 |
| Forceps holder | Spiggle & Theis Medizintechnik Gmbh | 1 |
| Voss 9″ Round Support | VM/Positioning, Inc. | 1 |
| Metal cup | Spiggle & Theis Medizintechnik Gmbh | 1 |
| Support, Head, Surgical, Ent | Medtronic Xomed, Inc. | 1 |
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.