NaviCath

FDA UDI

Class II (US FDA UDI)

by Myelotec, Inc.

Identity

Trade Name: NaviCath FDA UDI
Generic Name: Spinal infusion/drainage catheter FDA UDI
Device Name: NaviCath Steerable Catheter Kit FDA UDI
Model / Reference: 2017 FDA UDI
Description: NaviCath Steerable Catheter Kit FDA UDI

Identifiers

Catalog Number: 2017 FDA UDI
Primary DI / UDI-DI: M79320175 FDA UDI
FDA Product Code: HRX FDA UDI
GMDN Term: Spinal infusion/drainage catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Spinal infusion/drainage catheter

NaviCath by Myelotec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Myelotec, Inc.

Sources (1)

FDA UDI 2d91bf3a-a869-480a-a766-7b78e3d0246e 34 fields · synced May 29, 2026