Dash 6 NRFit™

FDA UDI

Class II (US FDA UDI)

by Intervene Group Limited

Identity

Trade Name: Dash 6 NRFit™ FDA UDI
Generic Name: Needle guide, single-use FDA UDI
Device Name: Dash 6, Introducer Needle, NRFit® Accessories, Single Use 18G x 38mm FDA UDI
Model / Reference: 15090002 FDA UDI
Description: Dash 6, Introducer Needle, NRFit® Accessories, Single Use 18G x 38mm FDA UDI

Identifiers

Catalog Number: 15090002 FDA UDI
Primary DI / UDI-DI: 05060498307345 FDA UDI
FDA Product Code: BSP FDA UDI
GMDN Term: Needle guide, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5150 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Needle guide, single-use

Dash 6 NRFit™ by Intervene Group Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Coaxial needle — Möller Medical GmbH · Class II
Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
Coaxial needle — Möller Medical GmbH · Class II
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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: Intervene Group Limited

Sources (1)

FDA UDI 35d46dae-b936-47ea-8c71-e845af8fc2b5 34 fields · synced Jun 8, 2026