ParaPost Fiber Lux

GUDID D661600199080

ParaPost Fiber Lux Training Kit

COLTENE/WHALEDENT INC

Root canal post, preformed

• Primary Device ID: D661600199080
• NIH Device Record Key: 23fa9c16-6940-44b7-b544-2d6c1eb04a29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ParaPost Fiber Lux
• Version Model Number: 60019908
• Company DUNS: 622185718
• Company Name: COLTENE/WHALEDENT INC
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840016201813 [Secondary]
HIBCC	D661600199080 [Unit of Use]
HIBCC	D661600199081 [Primary]

FDA Product Code

• ELR: Post, Root Canal

Sterilization

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

[D661600199080]

Moist Heat or Steam Sterilization

[D661600199080]

Moist Heat or Steam Sterilization

[D661600199080]

Moist Heat or Steam Sterilization

[D661600199080]

Moist Heat or Steam Sterilization

[D661600199080]

Moist Heat or Steam Sterilization

[D661600199080]

Moist Heat or Steam Sterilization

[D661600199080]

Moist Heat or Steam Sterilization

[D661600199080]

Moist Heat or Steam Sterilization

[D661600199080]

Moist Heat or Steam Sterilization

[D661600199080]

Moist Heat or Steam Sterilization

[D661600199080]

Moist Heat or Steam Sterilization

[D661600199080]

Moist Heat or Steam Sterilization

[D661600199080]

Moist Heat or Steam Sterilization

[D661600199080]

Moist Heat or Steam Sterilization

[D661600199080]

Moist Heat or Steam Sterilization

[D661600199080]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-06
• Device Publish Date: 2024-11-28

On-Brand Devices [ParaPost Fiber Lux]

• D661PF170C0: PARAPOST FIBER LUX INTRO KIT
• D66160018573C0: PARAPOST FIBER LUX 10 PK SIZE 6
• D66160018572C0: PARAPOST FIBER LUX 10 PK SIZE 5.5
• D66160018571C0: PARAPOST FIBER LUX 10 PK SIZE 5
• D66160018570C0: PARAPOST FIBER LUX 10 PK SIZE 4.5
• D66160018569C0: PARAPOST FIBER LUX 10 PK SIZE 4
• D66160018568C0: PARAPOST FIBER LUX 10 PK SIZE 3
• D661PF17161: 5 ParaPost FiberLux Posts, Size 6
• D661PF171551: 5 ParaPost FiberLux Posts, Size 5.5
• D661PF17151: 5 ParaPost FiberLux Posts, Size 5
• D661PF171451: 5 ParaPost FiberLux Posts, Size 4.5
• D661PF17141: 5 ParaPost FiberLux Posts, Size 4
• D661PF17131: 5 ParaPost FiberLux Posts, Size 3
• D661PF1701: ParaPost FiberLux Intro Kit
• D661600199080: ParaPost Fiber Lux Training Kit
• D661600185730: ParaPost Fiber Lux Size 6
• D661600185720: ParaPost Fiber Lux Size 5.5
• D661600185710: ParaPost Fiber Lux Size 5
• D661600185700: ParaPost Fiber Lux Size 4.5
• D661600185690: ParaPost Fiber Lux Size 4
• D661600185680: ParaPost Fiber Lux Size 3