Sterile electrode's cable STR-001419-22

GUDID 17290114064115

ALPHA OMEGA ENGINEERING CO. LTD.

Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use

• Primary Device ID: 17290114064115
• NIH Device Record Key: 4cd195ba-0c7a-461e-956b-5bda6b0f9e6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile electrode's cable
• Version Model Number: Sterile electrode's cable
• Catalog Number: STR-001419-22
• 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	07290114064118 [Primary]
GS1	17290114064115 [Package]; Contains: 07290114064118; 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: 2022-11-16
• Device Publish Date: 2022-11-08