Bore Gauge TruSystem 7500 US 117899

GUDID 04251269206719

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: 04251269206719
• NIH Device Record Key: 654102b5-0b23-4aaf-b0ca-433b890e3ac3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bore Gauge TruSystem 7500 US
• Version Model Number: 03
• Catalog Number: 117899
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251269206719 [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

On-Brand Devices [Bore Gauge TruSystem 7500 US]

• 04251269204579: 02
• 04251269200670: 01
• 04251269206719: Collision indicator for transfer during intraoperative brain surgery.