Rocket R57008-00-CN

GUDID 05055270977168

Copeland Fetal Scalp Electrode for Qwik Connect Cables

ROCKET MEDICAL PLC

Foetal scalp electrode, clip

• Primary Device ID: 05055270977168
• NIH Device Record Key: bc145a51-acaf-44ad-ba76-8aeb378c99b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rocket
• Version Model Number: R57008-00-CN
• Catalog Number: R57008-00-CN
• Company DUNS: 544313588
• Company Name: ROCKET MEDICAL PLC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055270977144 [Primary]
GS1	05055270977168 [Package]; Contains: 05055270977144; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K844608

FDA Product Code

• HGP: Electrode, Circular (Spiral), Scalp And Applicator

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: 2023-11-01
• Device Publish Date: 2023-10-24

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