Loop™ Calibration and Charging Base CLA02

GUDID 00810038093536

Loop™ Calibration and Charging Base Calibration and Charging Base

GARRISON DENTAL SOLUTIONS, L.L.C.

Dental/surgical polymerization lamp

• Primary Device ID: 00810038093536
• NIH Device Record Key: 743a99e7-a744-4a8e-925c-c7eb7a273dbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Loop™ Calibration and Charging Base
• Version Model Number: CLA02
• Catalog Number: CLA02
• Company DUNS: 057647005
• Company Name: GARRISON DENTAL SOLUTIONS, L.L.C.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8884370032
• Email: gds@garrisondental.com
• Phone: 8884370032
• Email: gds@garrisondental.com
• Phone: 8884370032
• Email: gds@garrisondental.com
• Phone: 8884370032
• Email: gds@garrisondental.com
• Phone: 8884370032
• Email: gds@garrisondental.com
• Phone: 8884370032
• Email: gds@garrisondental.com
• Phone: 8884370032
• Email: gds@garrisondental.com
• Phone: 8884370032
• Email: gds@garrisondental.com
• Phone: 8884370032
• Email: gds@garrisondental.com
• Phone: 8884370032
• Email: gds@garrisondental.com
• Phone: 8884370032
• Email: gds@garrisondental.com
• Phone: 8884370032
• Email: gds@garrisondental.com
• Phone: 8884370032
• Email: gds@garrisondental.com
• Phone: 8884370032
• Email: gds@garrisondental.com
• Phone: 8884370032
• Email: gds@garrisondental.com
• Phone: 8884370032
• Email: gds@garrisondental.com
• Phone: 8884370032
• Email: gds@garrisondental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810038093536 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200775

FDA Product Code

• EBZ: Activator, Ultraviolet, For Polymerization

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: 2023-05-01
• Device Publish Date: 2023-04-22

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