Codman Cerelink
CODMAN CERELINK Replacement Power Supply
5manufacturers in China registered for this device type
3catalogue numbers in this listing
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, serial number |
| Storage | Special storage condition: Keep Dry; Special storage condition: Waste from Electrical and Electronic Equipment; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -22 to 140 °F; Storage environment humidity 15 to 85 % RH; Handling environment temperature -22 to 140 °F |
| Distribution end date | 2022-09-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 826820 | Withdrawn | |
| 826824 | Withdrawn | |
| 826822 | Withdrawn |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.