Identity
- Trade Name
- Integra Spetzler™ Lumbar Peritoneal Shunt System FDA UDI
- Generic Name
- Spinal needle, single-use FDA UDI
- Device Name
- TUOHY NEEDLE 14g 6" for Lumbar Peritoneal Shunt A 6-inch FDA UDI
- Model / Reference
- NL82059S03 FDA UDI
- Description
- TUOHY NEEDLE 14g 6" for Lumbar Peritoneal Shunt A 6-inch FDA UDI
Identifiers
- Catalog Number
- NL82059S03 FDA UDI
- Primary DI / UDI-DI
- 10381780072195 FDA UDI
- 510(k) Number
- K811288 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Spinal needle, single-use 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
No
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: Spinal needle, single-use
Integra Spetzler™ Lumbar Peritoneal Shunt System by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K811288 also covers:
- Integra NeuroSciences Connector — Integra Lifesciences Corp.
- Integra Spetzler™ Lumbar Peritoneal Shunt System — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Natus® — Natus Medical Incorporated
- Natus® — Natus Medical Incorporated
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI 7d27a862-cb09-48e3-8c21-e7dee883e08a 37 fields · synced May 30, 2026