Digitest™ D640

GUDID M595D6400

Digitest™ II Digital Pulptester

PARKELL, INC.

Dental pulp analysis system

• Primary Device ID: M595D6400
• NIH Device Record Key: 40e221e3-c8f4-4ed8-ba06-8ea1dac6f1e9
• Commercial Distribution Discontinuation: 2019-01-01
• Commercial Distribution Status: Not 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M595D6400 [Primary]

FDA Product Code

• EAT: Tester, Pulp

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: 2019-04-01
• Device Publish Date: 2016-09-23

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)