Leadpoint 9033A0821AA

GUDID 00382830049375

Leadpoint Focus Workstation, US

NATUS MANUFACTURING LIMITED

Neurophysiologic monitoring system

• Primary Device ID: 00382830049375
• NIH Device Record Key: 1536b6c2-4d19-4dbb-b059-36fa7b9dae34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leadpoint
• Version Model Number: 9033A0821AA
• Catalog Number: 9033A0821AA
• Company DUNS: 896421240
• Company Name: NATUS MANUFACTURING LIMITED
• 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: true
• 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	00382830049375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140680

FDA Product Code

• GZL: Electrode, Depth

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: 2019-03-20
• Device Publish Date: 2019-03-12

On-Brand Devices [Leadpoint]

• 00382830053570: Leadpoint stimulus adaptor
• 00382830049399: Leadpoint Focus Workstation, US Intl. 115V
• 00382830049375: Leadpoint Focus Workstation, US
• 00382830049290: Leadpoint Focus Notebook, US
• 00382830049177: Macro Stimulator
• 00382830049146: MER Amplifier
• 00382830049092: Micro Electrode Cable, 5ch
• 00382830049085: Micro Electrode Cable, 3ch