Integra®
INTEGRA® Right Horseshoe Gel Pad and Base Assembly (Pediatric)
2manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Integra Lifesciences Corporation, United States |
|---|---|
| FDA product code | HBM |
| Device type | Headrest, Neurosurgical |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4440 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-04-13 |
| Record revised | 2025-04-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 440C1012 | 7″ Length x 2.5″ Width x 2″ Height | In distribution |
| 440C1011 | 6.5″ Length x 3″ Width x 2″ Height | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mayfield® | Integra Lifesciences Corporation | 28 |
| Headrest, Neurosurgical | Steris Corporation | 19 |
| 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 |
Showing 12 of 33. All products under Headrest, Neurosurgical
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.