Cannula STR-S19221-00

GUDID 17290114061008

ALPHA OMEGA ENGINEERING CO. LTD.

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• Primary Device ID: 17290114061008
• NIH Device Record Key: b94166f0-f0b2-453e-b843-173021c4ca77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannula
• Version Model Number: Standard
• Catalog Number: STR-S19221-00
• 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	07290114061001 [Primary]
GS1	17290114061008 [Package]; Contains: 07290114061001; Package: Carton [10 Units]; Discontinued: 2021-02-15; Not 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: 2021-02-25
• Device Publish Date: 2021-02-17

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