MoCo Insert 120435

GUDID 04251269206726

Collision indicator for transfer during intraoperative brain surgery.

Noras MRI products GmbH

Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp

• Primary Device ID: 04251269206726
• NIH Device Record Key: 92438ea8-dd08-4d12-bca0-9c6c5595dfba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MoCo Insert
• Version Model Number: 01
• Catalog Number: 120435
• Company DUNS: 312844095
• Company Name: Noras MRI products GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de
• Phone: +49934299270
• Email: mri@noras.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251269206726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133506

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-31
• Device Publish Date: 2021-03-23

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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.