Breast Biopsie Set Disposable 118943

GUDID 04251269203206

Noras MRI products GmbH

MRI system coil, radio-frequency

• Primary Device ID: 04251269203206
• NIH Device Record Key: 9dba0130-2ed5-4029-9121-4b4786f1b900
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breast Biopsie Set Disposable
• Version Model Number: 02
• Catalog Number: 118943
• Company DUNS: 312844095
• Company Name: Noras MRI products GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251269203206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010570

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-05
• Device Publish Date: 2018-07-13

Devices Manufactured by Noras MRI products GmbH

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• 04251269207358 - Breast BI 7 MR Coil Set 3T: 2023-09-18 The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breas
• 04251269207334 - Breast BI 7 MR Coil Set 1.5T: 2023-07-24 The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breas
• 04251269207327 - Breast BI 7 MR Coil Set 3T: 2023-05-30 The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breas
• 04251269207303 - OR Head Holder LUCY with HeadCoilSet Philips 1.5T: 2023-05-19 The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance Scann
• 04251269207310 - OR Head Holder LUCY with HeadCoilSet Philips 3T: 2023-05-19 The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance Scann
• 04251269203022 - Uni-Lift – Base Unit: 2022-07-14 The Uni-Lift is used for aiding MR guided prostate interventions such as prostate biopsy or therapy.
• 04251269203039 - Table Docking Uni-Lift for Siemens Aera/Skyra: 2022-07-14 The Uni-Lift is used for aiding MR guided prostate interventions such as prostate biopsy or therapy.