The product Localizer Adhesive pad Cranial is a product variant of a patient reference localisator for image guided surgical procedures. The adhesive pad is an accessory of the Localizer…
The product Localizer Adhesive pad Cranial is a product variant of a patient reference localisator for image guided surgical procedures. The adhesive pad is an accessory of the Localizer Adhesive Pad.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Localizer Adhesive pad Cranial | Listed by | Fiagon GMBH, Germany |
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer |
| 510(k) | K151156 |
| Record published | 2016-08-10 |
| Record revised | 2024-09-06 (version 8) |
Specifications
Specifications | MRI safety | MR Unsafe |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 30 to 75 % RH; Handling environment temperature 15 to 35 °C |
| Distribution end date | 2024-09-05 |
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.