GMPP Modified LSDS (HRDS) Options Kit for DCD

GUDID 00817495023854

GMPP Modified LSDS (HRDS) Options Kit for DCD

Candela Corporation

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• Primary Device ID: 00817495023854
• NIH Device Record Key: 0b090e55-9e09-40f5-b491-6821b2bdd425
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GMPP Modified LSDS (HRDS) Options Kit for DCD
• Version Model Number: FIN101958
• Company DUNS: 053468385
• Company Name: Candela Corporation
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495023854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201111

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2024-02-28
• Device Publish Date: 2024-02-20

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