FibreKleer 4x

GUDID 10814978023285

Fiber Post: Shape Parallel 5x 1.00 mm, 1.25 mm, 1.50 mm Posts; 1x 1.00 mm, 1.25 mm, 1.50 mm Drills

Kerr Corporation

Root canal post, preformed

• Primary Device ID: 10814978023285
• NIH Device Record Key: fed74768-5094-4570-b411-3499aff9e21e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FibreKleer 4x
• Version Model Number: N83A
• Company DUNS: 199354556
• Company Name: Kerr Corporation
• Device Count: 18
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814978023288 [Unit of Use]
GS1	10814978023285 [Primary]

FDA Product Code

• ELR: POST, ROOT CANAL

Sterilization

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

[10814978023285]

Moist Heat or Steam Sterilization

[10814978023285]

Moist Heat or Steam Sterilization

[10814978023285]

Moist Heat or Steam Sterilization

[10814978023285]

Moist Heat or Steam Sterilization

[10814978023285]

Moist Heat or Steam Sterilization

[10814978023285]

Moist Heat or Steam Sterilization

[10814978023285]

Moist Heat or Steam Sterilization

[10814978023285]

Moist Heat or Steam Sterilization

[10814978023285]

Moist Heat or Steam Sterilization

[10814978023285]

Moist Heat or Steam Sterilization

[10814978023285]

Moist Heat or Steam Sterilization

[10814978023285]

Moist Heat or Steam Sterilization

[10814978023285]

Moist Heat or Steam Sterilization

[10814978023285]

Moist Heat or Steam Sterilization

[10814978023285]

Moist Heat or Steam Sterilization

[10814978023285]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-12-09
• Device Publish Date: 2016-09-12

On-Brand Devices [FibreKleer 4x]

• 00814978022342: Fiber Post; 1.50 mm Tapered Drill
• 00814978022335: Fiber Post; 1.375 mm Tapered Drill
• 00814978022328: Fiber Post; 1.25 mm Tapered Drill
• 10814978023339: Fiber Reinforced Post; Shape - Original; Trial Kit; 5 x 1.25 mm Posts, 1 x 1.25 mm Drill
• 10814978023322: Fiber Post Shape Original 5x 1.00 mm 1.25 mm 1.50 mm Posts; 1x 1.00 mm, 1.25 mm, 1.50 mm Drills
• 10814978023315: Fiber Reinforced Post; Shape - Tapered; Trial Kit; 5 x 1.25 mm Posts, 1 x 1.25 mm Drill
• 10814978023308: Fiber Post Shape Tapered; 5x 1.25 mm, 1.375 mm, 1.50 mm Posts; 1x 1.25 mm, 1.375 mm, 1.50 mm Dri
• 10814978023292: Fiber Reinforced Post; Shape - Parallel; Trial Kit; 5 x 1.25 mm Posts, 1 x 1.25 mm Drill
• 10814978023285: Fiber Post: Shape Parallel 5x 1.00 mm, 1.25 mm, 1.50 mm Posts; 1x 1.00 mm, 1.25 mm, 1.50 mm Dril
• 10814978022523: Fiber Post; 1.50 mm Posts; Shape - Original
• 10814978022516: Fiber Post; 1.25 mm Posts; Shape - Original
• 10814978022509: Fiber Post; 1.00 mm Posts; Shape - Original
• 10814978022493: Fiber Post; 1.50 mm Posts; Shape - Original
• 10814978022486: Fiber Post; 1.25 mm Posts; Shape - Original
• 10814978022479: Fiber Post; 1.00 mm Posts; Shape - Original
• 10814978022462: Fiber Post; 1.50 mm Posts; Shape - Tapered
• 10814978022455: Fiber Post; 1.375 mm Posts; Shape - Tapered
• 10814978022448: Fiber Post; 1.25 mm Posts; Shape - Tapered
• 10814978022431: Fiber Post; 1.50 mm Posts; Shape - Tapered
• 10814978022424: Fiber Post; 1.375 mm Posts; Shape - Tapered
• 10814978022417: Fiber Post; 1.25 mm Posts; Shape - Tapered
• 10814978022400: Fiber Post; 1.50 mm Posts; Shape - Parallel
• 10814978022394: Fiber Post; 1.25 mm Posts; Shape - Parallel
• 10814978022387: Fiber Post; 1.00 mm Posts; Shape - Parallel
• 10814978022370: Fiber Post; 1.50 mm Posts; Shape - Parallel
• 10814978022363: Fiber Post; 1.25 mm Posts; Shape - Parallel
• 10814978022356: Fiber Post; 1.00 mm Posts; Shape - Parallel