LOOP™ CLK01

GUDID 00810038096506

Loop LED Curing LIght System

GARRISON DENTAL SOLUTIONS, L.L.C.

Dental/surgical polymerization lamp

• Primary Device ID: 00810038096506
• NIH Device Record Key: cac0c7cb-2ec1-4d94-8c54-b9f6f4b4cd4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOOP™
• Version Model Number: CLK01
• Catalog Number: CLK01
• 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: mmorris@garrisondental.com
• Phone: 8884370032
• Email: mmorris@garrisondental.com
• Phone: 8884370032
• Email: mmorris@garrisondental.com
• Phone: 8884370032
• Email: mmorris@garrisondental.com
• Phone: 8884370032
• Email: mmorris@garrisondental.com
• Phone: 8884370032
• Email: mmorris@garrisondental.com
• Phone: 8884370032
• Email: mmorris@garrisondental.com
• Phone: 8884370032
• Email: mmorris@garrisondental.com
• Phone: 8884370032
• Email: mmorris@garrisondental.com
• Phone: 8884370032
• Email: mmorris@garrisondental.com
• Phone: 8884370032
• Email: mmorris@garrisondental.com
• Phone: 8884370032
• Email: mmorris@garrisondental.com
• Phone: 8884370032
• Email: mmorris@garrisondental.com
• Phone: 8884370032
• Email: mmorris@garrisondental.com
• Phone: 8884370032
• Email: mmorris@garrisondental.com
• Phone: 8884370032
• Email: mmorris@garrisondental.com
• Phone: 8884370032
• Email: mmorris@garrisondental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810038096506 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200775

FDA Product Code

• EBZ: Activator, Ultraviolet, For Polymerization

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00810038096506]

High-level Disinfectant

[00810038096506]

High-level Disinfectant

[00810038096506]

High-level Disinfectant

[00810038096506]

High-level Disinfectant

[00810038096506]

High-level Disinfectant

[00810038096506]

High-level Disinfectant

[00810038096506]

High-level Disinfectant

[00810038096506]

High-level Disinfectant

[00810038096506]

High-level Disinfectant

[00810038096506]

High-level Disinfectant

[00810038096506]

High-level Disinfectant

[00810038096506]

High-level Disinfectant

[00810038096506]

High-level Disinfectant

[00810038096506]

High-level Disinfectant

[00810038096506]

High-level Disinfectant

[00810038096506]

High-level Disinfectant

[00810038096506]

High-level Disinfectant

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

On-Brand Devices [LOOP™]

• 20810038093561: Loop™ Protective Barrier Sleeves
• 00810038096506: Loop LED Curing LIght System
• 00810038096476: Loaner: Loop™ LED Curing Light System
• 00810038096469: Loaner: Loop™ Universal Power Supply and Adapters
• 00810038096452: Loaner: Loop™ Battery Kit
• 00810038093628: LOOP™ LED Curing Light Handpiece
• 00810038093611: Loaner: :Loop™ Calibration and Charging Base
• 00810038093604: Loaner: Loop™ LED Curing Light Handpiece
• 00810038093550: Loop™ Battery Kit
• 00810038093543: Loop™ Universal Power Supply and Adapters
• 00810038090870: Loop™ Lens Cleaning Cloth
• 00810038090863: Loop™ Protective Light Shield