Alcedo

GUDID 16973265920080

Suzhou Ennova Electronics Technology Co.,Ltd

Neuromuscular transmission electrode

• Primary Device ID: 16973265920080
• NIH Device Record Key: 95ffa300-3331-4662-9035-6db9ab86d106
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alcedo
• Version Model Number: P5050
• Company DUNS: 544324897
• Company Name: Suzhou Ennova Electronics Technology Co.,Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973265920076 [Primary]
GS1	16973265920080 [Package]; Contains: 06973265920076; Package: [2500 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152648

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-17
• Device Publish Date: 2020-09-09