C2 Xplore

GUDID 04250307610402

Body Box for C2 Xplore

inomed Medizintechnik GmbH

Nerve-function monitor

• Primary Device ID: 04250307610402
• NIH Device Record Key: 3df416f0-cecd-4427-a055-200c95603393
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C2 Xplore
• Version Model Number: 540431
• Company DUNS: 340782259
• Company Name: inomed Medizintechnik 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250307610402 [Primary]

FDA Product Code

• ETN: Stimulator, Nerve

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: 2024-08-05
• Device Publish Date: 2024-07-26

Devices Manufactured by inomed Medizintechnik GmbH

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• 14250307612052 - N/A: 2025-05-12 Laryngeal Electrode select + Needle electrode for tube with 6-7 mm inner diameter
• 14250307612069 - N/A: 2025-05-12 Laryngeal Electrode select + Needle electrode for tube with 7-9 mm inner diameter
• 14250307612076 - N/A: 2025-05-12 Laryngeal Electrode select for tube with 7-9 mm inner diameter
• 14250307612083 - N/A: 2025-05-12 Laryngeal Electrode select for tube with 6-7 mm inner diameter
• 04250307604517 - ISIS: 2025-04-08 AEP Insert Earphones for ISIS IOM Systems
• 04250307612154 - N/A: 2024-08-23 Imaging markers short for ceramic headring
• 04250307612161 - N/A: 2024-08-23 Imaging markers long for ceramic headring