Cerelink
CereLink ICP Extension Cable
5manufacturers in China registered for this device type
1catalogue number
12recalls on this code
Who Else Makes It
Concentrated in Guangdong (3), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Cerenovus, Inc., United States |
|---|---|
| FDA product code | GWM |
| Device type | Device, Monitoring, Intracranial Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1620 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K183406 |
| Record published | 2019-02-19 |
| Record revised | 2023-09-15 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Waste Electrical and Electronic Equipment; Handling environment temperature 0 to 50 °C; Handling environment temperature 32 to 122 °F; Storage environment humidity 15 to 85 % RH; Handling environment humidity 15 to 85 % RH; Storage environment temperature 0 to 50 °C |
| Distribution end date | 2022-09-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 82-6845 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Licox® | GMS, Gesellschaft für medizinische Sondentechnik mbH | 38 |
| Sophysa | Sophysa | 32 |
| Becker® | Medtronic PS Medical | 31 |
| Codman | Cerenovus, Inc. | 29 |
| Device, Monitoring, Intracranial Pressure | Medtronic PS Medical | 28 |
| Exacta™ | Medtronic PS Medical | 28 |
| Braincare | Braincare Desenvolvimento E Inovacao Tecnologica SA | 24 |
| Camino® | Integra Lifesciences (Ireland) Limited | 20 |
| Codman® | Integra LifeSciences Production Corporation | 19 |
| Integra® | Integra Lifesciences (Ireland) Limited | 17 |
| Aura | Branchpoint & Aura Development LLC | 17 |
| Natus | Natus Medical Incorporated | 15 |
Showing 12 of 133. All products under Device, Monitoring, Intracranial Pressure
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2019-09-12 | Class II | Under Investigation by firm | There is a potential for a progressive decline in observed ICP readings of the monitor during use. | 189 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-02-09 | Not classified | Nonconforming Material/Component | Codman ICP Skull Bolt wrench is out of specification and cannot be used to turn the screw on the drill | 4056 kits | 2015-09-11 |
| 2011-10-25 | Not classified | Labeling Change Control | Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits. | 861 units | 2015-05-29 |
| 2011-10-25 | Not classified | Labeling Change Control | Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits. | 462 units | 2015-05-29 |
| 2011-10-25 | Not classified | Labeling Change Control | Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits. | 2827 units | 2015-05-29 |
| 2011-10-25 | Not classified | Labeling Change Control | Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits. | 13845 units | 2015-05-29 |
| 2011-10-25 | Not classified | Labeling Change Control | Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits. | 254 units | 2015-05-29 |
| 2010-11-30 | Not classified | Package design/selection | Packaging defect may compromise sterility of device | 1671 units | 2013-03-14 |
| 2010-11-30 | Not classified | Package design/selection | Packaging defect may compromise sterility of device | 9038 units | 2013-03-14 |
| 2010-11-30 | Not classified | Package design/selection | Packaging defect may compromise sterility of device | 44 units | 2013-03-14 |
| 2010-11-30 | Not classified | Package design/selection | Packaging defect may compromise sterility of device | 226 units | 2013-03-14 |
| 2010-11-30 | Not classified | Package design/selection | Packaging defect may compromise sterility of device | 2264 units | 2013-03-14 |
| 2010-11-30 | Not classified | Package design/selection | Packaging defect may compromise sterility of device | 1549 units | 2013-03-14 |
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.