Alcedo

GUDID 16973265920080

Suzhou Ennova Electronics Technology Co.,Ltd

Neuromuscular transmission electrode Neuromuscular transmission electrode Neuromuscular transmission electrode Neuromuscular transmission electrode Neuromuscular transmission electrode Neuromuscular transmission electrode Neuromuscular transmission electrode Neuromuscular transmission electrode Neuromuscular transmission electrode Neuromuscular transmission electrode Neuromuscular transmission electrode Neuromuscular transmission electrode Neuromuscular transmission electrode 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