CODMAN MICROSENSOR 626631US
GUDID 10381780514473
CODMAN MICROSENSOR Basic Kit for Subdural/Intraparenchymal procedure
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Intracranial pressure monitor| Primary Device ID | 10381780514473 |
| NIH Device Record Key | e26a3e33-e61a-43ea-8ddc-fc7d74947ebb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CODMAN MICROSENSOR |
| Version Model Number | 626631US |
| Catalog Number | 626631US |
| Company DUNS | 081277700 |
| Company Name | INTEGRA LIFESCIENCES PRODUCTION CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
| Special Storage Condition, Specify | Between 0 and 0 *Waste from electrical and electronic equipment |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780514473 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153347
FDA Product Code
| GWM | Device, monitoring, intracranial pressure |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2020-02-28 |
On-Brand Devices [CODMAN MICROSENSOR]
| 10381780520504 | CODMAN MICROSENSOR Skull Bolt Kit Metal For Intraparenchymal Procedure |
| 10381780520429 | CODMAN MICROSENSOR Skull Bolt Kit Plastic For Intraparenchymal Procedure |
| 10381780520412 | CODMAN MICROSENSOR Basic Kit for Subdural/Intraparenchymal procedure |
| 10381780520405 | CODMAN MICROSENSOR Control Unit Cable |
| 10381780520320 | CODMAN MICROSENSOR Interface Control Unit |
| 10381780514534 | CODMAN MICROSENSOR Metal Skull Bolt Kit For Intraparenchymal Procedure |
| 10381780514497 | CODMAN MICROSENSOR Plastic Skull Bolt Kit For Intraparenchymal Procedure |
| 10381780514473 | CODMAN MICROSENSOR Basic Kit for Subdural/Intraparenchymal procedure |
Trademark Results [CODMAN MICROSENSOR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CODMAN MICROSENSOR 75327825 2300456 Live/Registered |
INTEGRA LIFESCIENCES CORPORATION 1997-07-21 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.