Packaged 15-Pack of Cryogen (R134a / 980g / JP)

GUDID 00817495023649

Packaged 15-Pack of Cryogen (R134a / 980g / JP)

Candela Corporation

Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system

• Primary Device ID: 00817495023649
• NIH Device Record Key: 41b7c596-7ad3-4c75-8cd2-fae6ffdf9297
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Packaged 15-Pack of Cryogen (R134a / 980g / JP)
• Version Model Number: 1600-00-0218
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495023649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001589

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: 2024-05-06
• Device Publish Date: 2024-04-26

Devices Manufactured by Candela Corporation

• 00817495020587 - Packaged 15-Pack of Cryogen (R134a / 980g / US): 2024-05-06 Packaged 15-Pack of Cryogen (R134a / 980g / US)
• 00817495023649 - Packaged 15-Pack of Cryogen (R134a / 980g / JP): 2024-05-06Packaged 15-Pack of Cryogen (R134a / 980g / JP)
• 00817495023649 - Packaged 15-Pack of Cryogen (R134a / 980g / JP): 2024-05-06 Packaged 15-Pack of Cryogen (R134a / 980g / JP)
• 00817495024370 - Profound, SubQ Single- Use Cartridge, Packaged: 2024-03-08 Profound, SubQ Single- Use Cartridge, Packaged
• 00817495024387 - Profound, Dermal Single- Use Cartridge, Packaged: 2024-03-08 Profound, Dermal Single- Use Cartridge, Packaged
• 00817495023854 - GMPP Modified LSDS (HRDS) Options Kit for DCD: 2024-02-28 GMPP Modified LSDS (HRDS) Options Kit for DCD
• 00817495023915 - GMPP Modified LSDS (HRDS) Options Kit for ACC: 2024-02-28 GMPP Modified LSDS (HRDS) Options Kit for ACC
• 00817495025032 - HRDS Handpiece DCD Cooled: 2024-02-28 HRDS Handpiece DCD Cooled
• 00817495025049 - HRDS Handpiece Air Cooled: 2024-02-28 HRDS Handpiece Air Cooled