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Integra®

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name
Integra® FDA UDI
Generic Name
Intracerebral infusion/drainage catheter, long-term FDA UDI
Device Name
Integra® Pudenz Catheter with Stylet FDA UDI
Model / Reference
NL8501228 FDA UDI
Description
Integra® Pudenz Catheter with Stylet FDA UDI

Identifiers

Catalog Number
NL8501228 FDA UDI
Primary DI / UDI-DI
10381780024262 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Intracerebral infusion/drainage catheter, long-term 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

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
MRI Safety
MR Conditional FDA UDI

Category: Intracerebral infusion/drainage catheter, long-term

Integra® by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intracerebral infusion/drainage catheter, long-term.

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 ed2461c8-db6c-4fd4-a950-7d4aee1053c0 36 fields · synced May 31, 2026