Headrest, Neurosurgical
The Eye-ENT-Neuro Headrest Adaptor is a specialized adaptor that accommodates all standard Eye-ENT-Neuro attachments and can be used with STERIS 5085, 4085, or Cmax General Surgical Tables.
2manufacturers in China registered for this device type
19catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hotry Co., Ltd. | Beijing | Beijing | Manufacturer | 9 |
Record
| Listed by | Steris Corporation, United States |
|---|---|
| FDA product code | HBM |
| Device type | Headrest, Neurosurgical |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4440 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-12-11 |
| Record revised | 2025-05-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-05-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HEAD02 | In distribution | |
| 7000 Series Head Support | In distribution | |
| Head Support | In distribution | |
| 7000 Series Head Support | In distribution | |
| BF008 | In distribution | |
| 7000 Series Head Support | In distribution | |
| 7000 Series Head Support | In distribution | |
| Head Support | In distribution | |
| BF011 | In distribution | |
| Head Support | In distribution | |
| Head Support | In distribution | |
| 7000 Series Head Support | In distribution | |
| 7000 Series Head Support | In distribution | |
| TAB830H | In distribution | |
| BF01 | In distribution | |
| Head Support | In distribution | |
| 7000 Series Head Support | In distribution | |
| Head Support | In distribution | |
| TAB830H | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mayfield® | Integra Lifesciences Corporation | 28 |
| Doro® Adaptor | Black Forest Medical GmbH | 7 |
| SBH | SBH Surgical | 5 |
| Doro® Gel Pad | Black Forest Medical GmbH | 5 |
| Doro® Base Unit | Black Forest Medical GmbH | 5 |
| Aesculap | Aesculap AG | 5 |
| Doro Lucent® iMRI Transfer Collision Indicator | Black Forest Medical GmbH | 5 |
| Horseshoe Headrest | Imris Imaging, Inc. | 4 |
| Fukushima Universal Holding System | Charmant, Inc. | 2 |
| Vertical Post Tilted | Charmant, Inc. | 2 |
| Doro Lucent® Transitional Member | Black Forest Medical GmbH | 2 |
| Doro® Table Adaptor | Black Forest Medical GmbH | 2 |
Showing 12 of 33. All products under Headrest, Neurosurgical
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Steris Corporation | UDI-DI | 2023-12-12 | Class II | Process control | Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay. | 2 |
| Steris Corporation | UDI-DI | 2023-12-12 | Class II | Process control | Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay. | 80 |
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.