NexDrive Electrode Holder 700-000316-02

GUDID 27290016450242

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode

• Primary Device ID: 27290016450242
• NIH Device Record Key: 12e7c92f-0ca8-4171-aaab-d8a72f5f8a8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexDrive Electrode Holder
• Version Model Number: NexDrive Electrode Holder - Pack of 2
• Catalog Number: 700-000316-02
• 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: false
• Lot Batch: true
• Serial Number: false
• 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	27290016450242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051830

FDA Product Code

• GZL: Electrode, Depth

Sterilization

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

[27290016450242]

Dry Heat Sterilization

[27290016450242]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-12
• Device Publish Date: 2020-05-04

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