Grid Biopsy Unit single use lateral Breast BI 7

FDA UDI

Class II (US FDA UDI)

by NORAS MRI products GmbH

Identity

Trade Name: Grid Biopsy Unit single use lateral Breast BI 7 FDA UDI
Generic Name: MRI system coil, radio-frequency FDA UDI
Device Name: The intended use of Breast BI 7 MR Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. FDA UDI
Model / Reference: 01 FDA UDI
Description: The intended use of Breast BI 7 MR Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. FDA UDI

Identifiers

Catalog Number: 121041 FDA UDI
Primary DI / UDI-DI: 04251269207051 FDA UDI
510(k) Number: K162651 FDA UDI
K180123 FDA UDI
FDA Product Code: MOS FDA UDI
GMDN Term: MRI system coil, radio-frequency FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1000 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

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: MRI system coil, radio-frequency

Grid Biopsy Unit single use lateral Breast BI 7 by NORAS MRI products GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as MRI system coil, radio-frequency.

Dunlee Sentinelle — Philips Medical Systems Nederland B.V. · Class II
16Ch Flex SPEEDER Pad Kit — NEOCOIL, LLC · Class II
ScanMed Long Bone (L) Coil — SCANMED, LLC · Class II
ScanMed Elbow Coil — SCANMED, LLC · Class II
Invivo — Philips DS North America LLC · Class II
TMJ COIL — Esaote S.p.A. · Class I
dS Flex Coil M 1.5T — Philips Healthcare (Suzhou) Co., Ltd. · Class IIb
Atlas SPEEDER Head-Neck Coil — QUALITY ELECTRODYNAMICS LLC · Class II

Cleared under the same submission

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: NORAS MRI products GmbH

Sources (1)

FDA UDI 850e0c2d-4f3a-4f6e-a3a9-6bc847522c33 36 fields · synced Jun 1, 2026