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Integra Spetzler™ Lumbar Peritoneal Shunt System

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name
Integra Spetzler™ Lumbar Peritoneal Shunt System FDA UDI
Generic Name
Lumboperitoneal shunt FDA UDI
Device Name
LONG SPETZLER 105CM LP SHUNT The Spetzler Lumbar Peritoneal Shunt System is designed to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid space to the peritoneum. Due to the small diameter of the catheter tubing, shunting may be accomplished by percutaneous techniques. A variety of devices are available: a one-piece model without a reservoir; separate large or small reservoirs that contain a one-way valve, which may be used when a flushing capability is required; and a separate miter valve, available in low, medium, or high pressure, which may be used when added resistance is desired. FDA UDI
Model / Reference
NL97105S01 FDA UDI
Description
LONG SPETZLER 105CM LP SHUNT The Spetzler Lumbar Peritoneal Shunt System is designed to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid space to the peritoneum. Due to the small diameter of the catheter tubing, shunting may be accomplished by percutaneous techniques. A variety of devices are available: a one-piece model without a reservoir; separate large or small reservoirs that contain a one-way valve, which may be used when a flushing capability is required; and a separate miter valve, available in low, medium, or high pressure, which may be used when added resistance is desired. FDA UDI

Identifiers

Catalog Number
NL97105S01 FDA UDI
Primary DI / UDI-DI
10381780072539 FDA UDI
510(k) Number
K101381 FDA UDI
K161992 FDA UDI
K811288 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Lumboperitoneal shunt 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

Yes

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: Lumboperitoneal shunt

Integra Spetzler™ Lumbar Peritoneal Shunt System by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lumboperitoneal shunt.

Cleared under the same submission

K101381 also covers:

K161992 also covers:

K811288 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 755bbac4-2b50-49c9-a208-66a797c3cb7c 37 fields · synced May 30, 2026