Codman® Bactiseal®

FDA UDI

Class II (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name: CODMAN® BACTISEAL® FDA UDI
Generic Name: Intracerebral infusion/drainage catheter, long-term FDA UDI
Device Name: CODMAN® BACTISEAL® Clear with Barium Stripe Catheter Kit MR Conditional Contents: Ventricular Catheter 15cm (1), Distal Catheter 120cm (1), Right Angle Adapter (1); Additional contents: Stylet (1) FDA UDI
Model / Reference: NS0340 FDA UDI
Description: CODMAN® BACTISEAL® Clear with Barium Stripe Catheter Kit MR Conditional Contents: Ventricular Catheter 15cm (1), Distal Catheter 120cm (1), Right Angle Adapter (1); Additional contents: Stylet (1) FDA UDI

Identifiers

Catalog Number: NS0340 FDA UDI
Primary DI / UDI-DI: 10381780537076 FDA UDI
FDA Product Code: JXG FDA UDI
HCA 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
882.4100 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Catheter Length — 120 Centimeter FDA UDI
Catheter Length — 15 Centimeter FDA UDI

Category: Intracerebral infusion/drainage catheter, long-term Peritoneal/atrial cerebrospinal fluid catheter

Codman® Bactiseal® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peritoneal/atrial cerebrospinal fluid catheter.

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Integra® — Integra Lifesciences Corp. · Class II
Integra® — Integra Lifesciences Corp. · Class II
Natus® — Natus Medical Incorporated · Class II

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 Production Corporation

Sources (1)

FDA UDI ad7c793e-afaf-46bf-91fa-3be17e9729e5 37 fields · synced Jun 9, 2026