Sterile neuroprobe STR-000080-00

GUDID 17290114061770

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode

• Primary Device ID: 17290114061770
• NIH Device Record Key: b38240f0-bf43-43f9-875f-6bf2b944e06c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile neuroprobe
• Version Model Number: Shielded
• Catalog Number: STR-000080-00
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290114061773 [Primary]
GS1	17290114061770 [Package]; Contains: 07290114061773; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120098

FDA Product Code

• GZL: Electrode, Depth

Sterilization

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

[17290114061770]

Moist Heat or Steam Sterilization

[17290114061770]

Moist Heat or Steam Sterilization

[17290114061770]

Moist Heat or Steam Sterilization

[17290114061770]

Moist Heat or Steam Sterilization

[17290114061770]

Moist Heat or Steam Sterilization

[17290114061770]

Moist Heat or Steam Sterilization

[17290114061770]

Moist Heat or Steam Sterilization

[17290114061770]

Moist Heat or Steam Sterilization

[17290114061770]

Moist Heat or Steam Sterilization

[17290114061770]

Moist Heat or Steam Sterilization

[17290114061770]

Moist Heat or Steam Sterilization

[17290114061770]

Moist Heat or Steam Sterilization

[17290114061770]

Moist Heat or Steam Sterilization

[17290114061770]

Moist Heat or Steam Sterilization

[17290114061770]

Moist Heat or Steam Sterilization

[17290114061770]

Moist Heat or Steam Sterilization

[17290114061770]

Moist Heat or Steam Sterilization

[17290114061770]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-22
• Device Publish Date: 2023-05-12

On-Brand Devices [Sterile neuroprobe ]

• 17290114061770: Shielded
• 17290114062319: Shielded
• 17290114062258: Non-Shielded
• 17290114062241: Shielded
• 17290114062234: Shielded
• 17290114062029: Non-Shielded
• 17290114062012: Non-Shielded
• 17290114062005: Non-Shielded
• 17290114061992: Non-Shielded
• 17290114061985: Shielded
• 17290114061978: Shielded
• 17290114061961: Shielded
• 17290114061954: Shielded
• 17290114061947: Shielded
• 17290114061930: Shielded
• 17290114061923: Shielded
• 17290114061916: Non-Shielded
• 17290114061909: Non-Shielded
• 17290114061886: Non-Shielded
• 17290114061879: Non-Shielded
• 17290114061862: Non-Shielded
• 17290114061855: Shielded
• 17290114061848: Non-Shielded
• 17290114061831: Non-Shielded
• 17290114061824: Non-Shielded
• 17290114061800: Shielded
• 17290114061794: Shielded
• 17290114061787: Shielded
• 17290114061534: Non-Shielded