Sterile cannula STR-021621-00

GUDID 17290114061565

ALPHA OMEGA ENGINEERING CO. LTD.

Intracerebral cannula, implantable

• Primary Device ID: 17290114061565
• NIH Device Record Key: 2bea8207-3fc7-4630-8668-ec8baf7f6d6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile cannula
• Version Model Number: Sterile cannula
• Catalog Number: STR-021621-00
• 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: true
• 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	07290114061568 [Primary]
GS1	17290114061565 [Package]; Contains: 07290114061568; 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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-25
• Device Publish Date: 2023-05-17

On-Brand Devices [Sterile cannula]

• 17290114062111: Sterile cannula
• 17290114062104: Sterile cannula
• 17290114063439: Sterile cannula
• 17290114063392: Sterile cannula
• 17290114063385: Sterile cannula
• 17290114063378: Sterile cannula
• 17290114063361: Sterile cannula
• 17290114063354: Sterile cannula
• 17290114063347: Sterile cannula
• 17290114063330: Sterile cannula
• 17290114062227: Sterile cannula
• 17290114062180: Sterile cannula
• 17290114062173: Sterile cannula
• 17290114062142: Sterile cannula
• 17290114062135: Sterile cannula
• 17290114062128: Sterile cannula
• 17290114062098: Sterile cannula
• 17290114062081: Sterile cannula
• 17290114062074: Sterile cannula
• 17290114062067: Sterile cannula
• 17290114062050: Sterile cannula
• 17290114062043: Sterile cannula
• 17290114061565: Sterile cannula
• 17290114062296: Sterile cannula
• 17290114062203: Sterile cannula
• 17290114062197: Sterile cannula
• 17290114062166: Sterile cannula
• 17290114062159: Sterile cannula