ISIS

GUDID 04250307607563

ISIS Headbox 8 Ch. Dif- 8 Ch. REF- AEP

inomed Medizintechnik GmbH

Nerve-function monitor

• Primary Device ID: 04250307607563
• NIH Device Record Key: b228bb65-64f0-440c-8c53-9dcb27998b63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISIS
• Version Model Number: 504285
• Company DUNS: 340782259
• Company Name: inomed Medizintechnik 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250307607563 [Primary]

FDA Product Code

• GWF: Stimulator, Electrical, Evoked Response

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: 2022-09-13
• Device Publish Date: 2022-09-05

On-Brand Devices [ISIS]

• 04250307609017: ISIS Headbox 16 Ch. REF-AEP
• 04250307609000: ISIS Headbox 16 Ch. DIF
• 04250307608997: ISIS Headbox 16 Ch. REF
• 04250307607563: ISIS Headbox 8 Ch. Dif- 8 Ch. REF- AEP
• 04250307607440: ISIS Neurostimulator
• 04250307604517: AEP Insert Earphones for ISIS IOM Systems