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Grid Biopsy Unit disposable medial Breast BI 7

FDA UDI

Class II (US FDA UDI)

by NORAS MRI products GmbH

Identity

Trade Name
Grid Biopsy Unit disposable medial Breast BI 7 FDA UDI
Generic Name
MRI system coil, radio-frequency FDA UDI
Model / Reference
01 FDA UDI

Identifiers

Catalog Number
118979 FDA UDI
Primary DI / UDI-DI
04251269202704 FDA UDI
510(k) Number
K162651 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

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

Cleared under the same submission

K162651 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
NORAS MRI products GmbH

Sources (1)

  • FDA UDI e9f7f366-538b-401a-8b20-cd9a0a7ff171 36 fields · synced Jun 6, 2026