Foramatron® D619WAE

GUDID 00810000520268

Wire Assembly with 2-Ground Clips for Foramatron® IV D610E E

PARKELL, INC.

Endodontic apex locator

• Primary Device ID: 00810000520268
• NIH Device Record Key: fd3a6cf2-369d-49d5-9875-c88595b09c52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foramatron®
• Version Model Number: D619WAE
• Catalog Number: D619WAE
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000520268 [Primary]

FDA Product Code

• LQY: Locator, Root Apex

Sterilization

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

[00810000520268]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-26
• Device Publish Date: 2019-08-16

On-Brand Devices [Foramatron®]

• 00810000520275: The Foramatron® Electronic Apex Locator
• 00810000520251: Universal Reamer Holder for Foramatron® All Models
• 00810000520237: Quick Probe for Foramatron® All Models
• 00810000520220: Touch-Proof Wire Assembly for Model D-10 Foramatron® (Includes: Lip Clips, Quick Test Probe Rea
• M595D6450: The Foramatron® Electronic Apex Locator
• M595D619RH0: Universal Reamer Holder for Foramatron® All Models
• M595D6130: Quick Probe for Foramatron® All Models
• M595D6110: Touch-Proof Wire Assembly for Model D-10 Foramatron® (Includes: Lip Clips, Quick Test Probe Rea
• 00810000520268: Wire Assembly with 2-Ground Clips for Foramatron® IV D610E E