Rocket R57008-00-CN

GUDID 05055270977168

Copeland Fetal Scalp Electrode for Qwik Connect Cables

ROCKET MEDICAL PLC

Foetal scalp electrode, clip Foetal scalp electrode, clip Foetal scalp electrode, clip Foetal scalp electrode, clip Foetal scalp electrode, clip Foetal scalp electrode, clip Foetal scalp electrode, clip Foetal scalp electrode, clip Foetal scalp electrode, clip Foetal scalp electrode, clip Foetal scalp electrode, clip Foetal scalp electrode, clip Foetal scalp electrode, clip Foetal scalp electrode, clip Foetal scalp electrode, clip Foetal scalp electrode, clip 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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