Foramatron® D619RH

GUDID 00810000520251

Universal Reamer Holder for Foramatron® All Models

PARKELL, INC.

Endodontic apex locator Endodontic apex locator

• Primary Device ID: 00810000520251
• NIH Device Record Key: 83882fdd-d2ee-4fa6-9295-f60334a18bf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foramatron®
• Version Model Number: D619RH
• Catalog Number: D619RH
• Company DUNS: 009900424
• Company Name: PARKELL, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000520251 [Primary]

FDA Product Code

• LQY: Locator, Root Apex

Sterilization

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

[00810000520251]

Moist Heat or Steam Sterilization

[00810000520251]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-17
• Device Publish Date: 2018-11-16

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