LeadConfirm STR-000055-00

GUDID 17290114060421

ALPHA OMEGA ENGINEERING CO. LTD.

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• Primary Device ID: 17290114060421
• NIH Device Record Key: 1cec0107-c43a-437c-a766-121ddf1ca0a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LeadConfirm
• Version Model Number: Sterile Neuro Omega LeadConfirm B Cable
• Catalog Number: STR-000055-00
• Company DUNS: 531856466
• Company Name: ALPHA OMEGA ENGINEERING CO. LTD.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	07290114060424 [Primary]
GS1	17290114060421 [Package]; Contains: 07290114060424; Package: Carton [10 Units]; Discontinued: 2021-03-01; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191739

FDA Product Code

• GZL: Electrode, Depth

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-12
• Device Publish Date: 2021-03-04

On-Brand Devices [LeadConfirm]

• 17290114061084: Sterile NeuroSmart/NeuroNav MER LeadConfirm M_S Ca
• 07290114061070: Sterile NeuroSmart/NeuroNav MER LeadConfirm M Cabl
• 17290114061060: Sterile NeuroSmart/NeuroNav LeadConfirm M_S Cable
• 17290114061053: Sterile Neuro Omega MER LeadConfirm M_S Cable
• 17290114061046: Sterile LeadConfirm M_S Cable
• 17290114060865: Sterile NeuroSmart/NeuroNav LeadConfirm M Adaptor
• 17290114060834: Sterile Neuro Omega LeadConfirm A Adaptor
• 17290114060476: Sterile Neuro Omega LeadConfirm A Adaptor
• 17290114060452: Sterile Neuro Omega LeadConfirm M Adaptor
• 17290114060445: Sterile Neuro Omega LeadConfirm A Cable
• 17290114060421: Sterile Neuro Omega LeadConfirm B Cable
• 07290114060417: Sterile Neuro Omega LeadConfirm M Cable