CODMAN CERTAS 828859
GUDID 00381780521337
CODMAN CERTAS X-Ray Overlay Tool
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer| Primary Device ID | 00381780521337 |
| NIH Device Record Key | 9bd86e5a-8c5d-4c36-b5eb-a978ce583f22 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CODMAN CERTAS |
| Version Model Number | 82-8859 |
| Catalog Number | 828859 |
| Company DUNS | 081277700 |
| Company Name | INTEGRA LIFESCIENCES PRODUCTION CORPORATION |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00381780521337 [Unit of Use] |
| GS1 | 10381780521334 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143111
FDA Product Code
| JXG | Shunt, central nervous system and components |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-09 |
| Device Publish Date | 2020-02-28 |
On-Brand Devices [CODMAN CERTAS]
| 10381780521358 | CODMAN CERTAS REPLACEMENT TOOL, ADJUSTABLE HEIGHT LOCATOR for use ONLY as part of the CODMAN CER |
| 10381780521341 | CODMAN CERTAS REPLACEMENT TOOL, INDICATOR for use ONLY as part of the CODMAN CERTAS TOOL KIT (RE |
| 00381780521337 | CODMAN CERTAS X-Ray Overlay Tool |
| 10381780521327 | CODMAN CERTAS Tool Kit |
Trademark Results [CODMAN CERTAS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CODMAN CERTAS 77852450 4179795 Live/Registered |
INTEGRA LIFESCIENCES CORPORATION 2009-10-20 |
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