Ball-Point Applicators

GUDID 00615375005279

Disposable BallPoint Micro Applicators

METREX RESEARCH, LLC

Dental material application tool, single-use Dental material application tool, single-use

• Primary Device ID: 00615375005279
• NIH Device Record Key: 857d0bca-a6ad-44ba-9743-df04a42ce78c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ball-Point Applicators
• Version Model Number: 8300-FC
• Company DUNS: 145963778
• Company Name: METREX RESEARCH, LLC
• Device Count: 250
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +18008411428
• Email: customercare@kavokerrgroup.com
• Phone: +18008411428
• Email: customercare@kavokerrgroup.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00615375005279 [Primary]
GS1	00615375007839 [Unit of Use]

FDA Product Code

• KXR: APPLICATOR, RESIN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-08-31

On-Brand Devices [Ball-Point Applicators]

• 00615375005286: Disposable BallPoint Micro Applicators
• 00615375005279: Disposable BallPoint Micro Applicators