Cannula STR-000021-31

GUDID 07290014954649

ALPHA OMEGA ENGINEERING CO. LTD.

Intracerebral cannula, implantable

• Primary Device ID: 07290014954649
• NIH Device Record Key: c7b23459-5000-4030-a21a-a80f0f9742a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannula
• Version Model Number: Standard
• Catalog Number: STR-000021-31
• 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

Customer Support Contacts

• Phone: 8779196288
• Email: m.andrea@alphaomega-eng.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290014954649 [Primary]
GS1	17290014954646 [Package]; 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-22
• Device Publish Date: 2016-09-24

On-Brand Devices [Cannula]

• 07290016450828: insertion tube Array electrode
• 07290016450804: Insertion Tube Set 15mm above
• 07290016450798: Insertion Tube Set 20mm above
• 07290016450781: Insertion Tube Set 40mm above
• 07290016450774: Lead Insertion Tube
• 07290016450767: Extractor
• 07290016450750: Stylet without Cannula
• 07290016450743: Tapered
• 17290016450733: Tapered
• 07290016450729: Standard Without Stylet
• 07290016450712: Standard
• 07290016450705: Standard
• 07290016450699: Standard
• 07290016450682: Standard
• 07290016450675: Standard
• 07290016450668: Standard
• 07290016450651: Standard
• 07290016450644: Standard
• 07290016450637: Standard
• 17290014954905: Standard
• 17290014954899: Standard
• 07290014954823: Array electrode insertion tube
• 07290014954809: Insertion Tube Set 15mm above
• 07290014954793: Insertion Tube Set 20mm above
• 07290014954762: Extractor
• 07290014954755: Stylet
• 07290014954748: Tapered
• 07290014954731: Tapered
• 07290014954717: Standard
• 07290014954700: Standard
• 07290014954694: Standard
• 07290014954687: Standard
• 07290014954670: Standard
• 07290014954663: Standard
• 07290014954656: Standard
• 07290014954649: Standard
• 07290014954632: Standard
• 17290114060407: Sterile Nexframe/Starfix Stainless Steel Guide Tube (cannula) and Stylet
• 07290114061094: Standard
• 17290114061039: Standard
• 07290114061025: Standard
• 17290114061015: Standard
• 17290114061008: Standard
• 07290114060998: Standard
• 07290114060981: Standard
• 07290114060974: Standard
• 17290014954103: Sterile Nexframe/Starfix Stainless Steel Guide Tube (cannula) and Stylet