MoCo Insert 120435

GUDID 04251269206726

Collision indicator for transfer during intraoperative brain surgery.

Noras MRI products GmbH

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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• 04251269207402 - iLoop Interventional Coil 0.55T: 2025-04-17 The intended use of the iLoop Interventional Coil 0.55T is, in conjunction with a Magnetic Resonance Scanner, the MR examination
• 04251269207365 - Breast BI 7 MR Coil Set 1.5T: 2025-03-19 The intended use of Breast BI 7 MR Coil Set 1.5T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the
• 04251269207372 - Breast BI 7 MR Coil 1.5T: 2025-03-19 The intended use of Breast BI 7 MR Coil Set 1.5T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the
• 04251269207297 - iLoop Interventional Coil 0.55T: 2024-06-19 The intended use of the iLoop Interventional Coil 0.55T is, in conjunction with a Magnetic Resonance Scanner, the MR examination
• 04251269207341 - Breast BI 7 MR Coil Set 1.5T: 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
• 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