Sterile LeadConfirm STR-000078-00

GUDID 17290114063811

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 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 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 Electrical-only medical device connection cable, single-use

• Primary Device ID: 17290114063811
• NIH Device Record Key: 0d4f0b44-7410-4cda-9522-63ddd2cd84c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile LeadConfirm
• Version Model Number: Sterile LeadConfirm
• Catalog Number: STR-000078-00
• 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	07290114063814 [Primary]
GS1	17290114063811 [Package]; Contains: 07290114063814; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191739

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: 2023-05-24
• Device Publish Date: 2023-05-16

On-Brand Devices [Sterile LeadConfirm]

• 17290114064474: Sterile LeadConfirm
• 17290114064467: Sterile LeadConfirm
• 17290114064450: Sterile LeadConfirm
• 17290114064443: Sterile LeadConfirm
• 17290114064436: Sterile LeadConfirm
• 17290114064313: Sterile LeadConfirm
• 17290114064429: Sterile LeadConfirm
• 17290114064412: Sterile LeadConfirm
• 07290114064392: Sterile LeadConfirm
• 17290114064399: Sterile LeadConfirm
• 17290114064382: Sterile LeadConfirm
• 17290114064375: Sterile LeadConfirm
• 17290114064368: Sterile LeadConfirm
• 17290114064351: Sterile LeadConfirm
• 17290114064344: Sterile LeadConfirm
• 17290114064337: Sterile LeadConfirm
• 17290114064320: Sterile LeadConfirm
• 17290114064306: Sterile LeadConfirm
• 17290114064290: Sterile LeadConfirm
• 17290114063989: Sterile LeadConfirm
• 17290114063828: Sterile LeadConfirm
• 17290114063408: Sterile LeadConfirm
• 17290114063231: Sterile LeadConfirm
• 17290114063040: Sterile LeadConfirm
• 17290114063033: Sterile LeadConfirm
• 17290114063026: Sterile LeadConfirm
• 17290114063002: Sterile LeadConfirm
• 17290114062999: Sterile LeadConfirm
• 17290114062333: Sterile LeadConfirm
• 17290114064009: Sterile LeadConfirm
• 17290114063996: Sterile LeadConfirm
• 07290114063845: Sterile LeadConfirm
• 17290114063835: Sterile LeadConfirm
• 17290114063811: Sterile LeadConfirm
• 17290114063804: Sterile LeadConfirm
• 17290114063415: Sterile LeadConfirm
• 17290114063262: Sterile LeadConfirm
• 17290114061497: Sterile LeadConfirm