MRI Needle Guide SNG

FDA UDI

Class I (US FDA UDI)

by BIP Biomedizinische Instrumente und Produkte GmbH

Identity

Trade Name: MRI Needle Guide SNG FDA UDI
Generic Name: Needle guide, single-use FDA UDI
Device Name: MRI Needle Guide SNG for Soteria RCM Ø2,2x130mm FDA UDI
Model / Reference: SNG18150 FDA UDI
Description: MRI Needle Guide SNG for Soteria RCM Ø2,2x130mm FDA UDI

Identifiers

Primary DI / UDI-DI: 04251135812099 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Needle guide, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Needle guide, single-use

MRI Needle Guide SNG by BIP Biomedizinische Instrumente und Produkte GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Needle guide, single-use.

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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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InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · 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 I	Pending data

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Manufacturer

Manufacturer: BIP Biomedizinische Instrumente und Produkte GmbH

Sources (1)

FDA UDI 4a4647b9-c2f1-40bc-b30d-ddcdcbb0003f 34 fields · synced Jun 8, 2026