Hermetic™ External Drainage Lumbar Catheter SP0224
GUDID 10381780072553
LUMBAR CATHETER CLOSED TIP The 80cm barium impregnated silicone lumbar catheter has a closed radiopaque tip and is supplied with a Teflon coated stainless steel guide wire and end stop for assisting catheter placement. Approximately 18mm of the tip is multi-perforated to help improve flow and decrease the possibility of obstruction. Designed for diverting fluid from the lumbar subarachnoid space, the catheter can be inserted with a Tuohy needle using percutaneous techniques. The external portion of the catheter is secured to the subcutaneous tissue in the lumbar area by the suture collar. A 14-guage thin wall Tuohy needle with obturator, guide wire, and 22-gauge blunt needle are included. A female luer adapter and train relief tubing is also included. Two suture collars may be wrapped around the catheter and may be anchored in place with a suture.
Integra Lifesciences Corporation
Lumbar cerebrospinal fluid drainage kit| Primary Device ID | 10381780072553 |
| NIH Device Record Key | 3bed075f-6137-425c-9ff2-09939071d398 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hermetic™ External Drainage Lumbar Catheter |
| Version Model Number | SP0224 |
| Catalog Number | SP0224 |
| Company DUNS | 083171244 |
| Company Name | Integra Lifesciences Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780072553 [Primary] |
| HIBCC | M269SP02241 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K970658
FDA Product Code
| JXG | Shunt, central nervous system and components |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-09-22 |
| Device Publish Date | 2015-09-22 |
Devices Manufactured by Integra Lifesciences Corporation
| 10381780537182 - MAYFIELD® | 2025-09-02 MAYFIELD® Ghost™ Base Unit, Post |
| M24841C14441 - MAYFIELD® | 2025-04-02 Left Horseshoe Gel Pad |
| M24841C14451 - MAYFIELD® | 2025-04-02 Right Horseshoe Gel Pad |
| M248A1008P1 - MAYFIELD® | 2025-04-02 POOL - MAYFIELD GENERAL PURPOSE HEADREST |
| M248A1011P1 - MAYFIELD® | 2025-04-02 POOL- MAYFIELD HORSESHOE HEADREST |
| M248A1011SRL1 - MAYFIELD® | 2025-04-02 MAYFIELD HORSESHOE HEADREST |
| M248A1012P1 - MAYFIELD® | 2025-04-02 POOL - MAYFIELD SWIVEL HORSESHOE HEADREST |
| M248A1012SRL1 - MAYFIELD® | 2025-04-02 MAYFIELD SWIVEL HORSESHOE HEADREST |
Trademark Results [Hermetic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HERMETIC 88718200 not registered Live/Pending |
HANGZHOU POWERPACK BATTERY CO.,LTD 2019-12-06 |
 HERMETIC 79339810 not registered Live/Pending |
Fidlock GmbH 2022-01-14 |
 HERMETIC 79120098 not registered Dead/Abandoned |
CHIBRO S.P.A. 2012-08-06 |
 HERMETIC 74120153 not registered Dead/Abandoned |
Warrender, LTD. 1990-12-03 |
 HERMETIC 73432550 not registered Dead/Abandoned |
AMERICAN HOSPITAL SUPPLY CORPORATION 1983-06-29 |
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