Grid Biopsy Unit single use medial Breast BI 7 121038

GUDID 04251269207020

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.

Noras MRI products GmbH

MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency

Primary Device ID	04251269207020
NIH Device Record Key	7bd18b75-e574-4580-b511-ddc7f015564c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Grid Biopsy Unit single use medial Breast BI 7
Version Model Number	01
Catalog Number	121038
Company DUNS	312844095
Company Name	Noras MRI products GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+49931299270
Email	sales@noras.de
Phone	+49931299270
Email	sales@noras.de
Phone	+49931299270
Email	sales@noras.de
Phone	+49931299270
Email	sales@noras.de
Phone	+49931299270
Email	sales@noras.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251269207020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162651

FDA Product Code

MOS	Coil, Magnetic Resonance, Specialty