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® Catheters MR Conditional Contents: Ventricular Catheter 15cm (1), Right Angle Adapter (1); Additional Contents: Stylet (1) FDA UDI
Model / Reference: NS5075 FDA UDI
Description: CODMAN® BACTISEAL® Catheters MR Conditional Contents: Ventricular Catheter 15cm (1), Right Angle Adapter (1); Additional Contents: Stylet (1) FDA UDI

Identifiers

Catalog Number: NS5075 FDA UDI
Primary DI / UDI-DI: 10381780537120 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 — 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.

Integra® — Integra Lifesciences Corp. · Class II
AESCULAP — Christoph Miethke GmbH & Co. KG · Class II
Phoenix Neuro — Sophysa SA · Class II
Natus® — Natus Medical Incorporated · Class II
Natus® — Natus Medical Incorporated · Class II
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Integra LifeSciences Production Corporation

Sources (1)

FDA UDI ec7352d1-c7d3-4377-86fb-b7f2fc345cdc 37 fields · synced Jun 9, 2026