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Hermetic™ External Drainage Lumbar Catheter

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name
Hermetic™ External Drainage Lumbar Catheter FDA UDI
Generic Name
Lumbar cerebrospinal fluid drainage catheterization kit FDA UDI
Device Name
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. FDA UDI
Model / Reference
SP0224 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
SP0224 FDA UDI
Primary DI / UDI-DI
10381780072553 FDA UDI
510(k) Number
K970658 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Lumbar cerebrospinal fluid drainage catheterization kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Lumbar cerebrospinal fluid drainage catheterization kit

Hermetic™ External Drainage Lumbar Catheter by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lumbar cerebrospinal fluid drainage catheterization kit.

Cleared under the same submission

K970658 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra Lifesciences Corp.

Sources (1)

  • FDA UDI 3bed075f-6137-425c-9ff2-09939071d398 37 fields · synced May 30, 2026