Digitest™ D640

GUDID 00810000520497

Digitest™ II Digital Pulptester

PARKELL, INC.

Dental pulp analysis system

• Primary Device ID: 00810000520497
• NIH Device Record Key: 1919d73e-c487-4de0-8ad3-329b6decc01a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digitest™
• Version Model Number: D640
• Catalog Number: D640
• Company DUNS: 009900424
• Company Name: PARKELL, INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• Manufacturing Date: true
• 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	00810000520497 [Primary]

FDA Product Code

• EAT: Tester, Pulp

Sterilization

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

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

On-Brand Devices [Digitest™]

• 00810000520503: Digitest™ II Digital Pulptester
• 00810000520497: Digitest™ II Digital Pulptester
• M595D6400: Digitest™ II Digital Pulptester
• 00810000520862: Digitest™ 3 Digital Pulptester
• 00810000520657: Digitest™ II Digital Pulptester (Japan)