Gentle Pulse™ D636

GUDID M595D6360

Precision Probe Set for Gentle Pulse™ & Digitest™ Pulptesters (1-each Facial & Lingual Probes)

PARKELL, INC.

Dental pulp analysis system

• Primary Device ID: M595D6360
• NIH Device Record Key: 11485047-0d48-44d5-abbb-0c645bf2b17e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gentle Pulse™
• Version Model Number: D636
• Catalog Number: D636
• 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
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000520480 [Primary]
HIBCC	M595D6360 [Previous]

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: 2018-10-15
• Device Publish Date: 2018-09-14

On-Brand Devices [Gentle Pulse™]

• M595D6360: Precision Probe Set for Gentle Pulse™ & Digitest™ Pulptesters (1-each Facial & Lingual Probe
• 00810000520473: Ground Clip and Lead Wire for Gentle Pulse™ & Digitest™ Pulptesters
• 00810000520466: Ground Clip Lead Wire & Adaptor for Gentle Pulse™ & Digitest™ Pulptesters (Complies with New
• 00810000520459: Metal Probes for Gentle Pulse™ & Digitest™ Pulptesters (1-Short & 1-Long)
• 00810000520442: Gentle Pulse™ Pulp Vitality Tester
• 00810000520435: Gentle Pulse™ Pulp Vitality Tester
• M595D624MS0: Gentle Pulse™ Pulp Vitality Tester
• 00810000520978: Gentle Pulse™ Pulp Vitality Tester (Korea)
• 00810000520961: Metal Probes for Gentle Pulse™ & Digitest™ Pulptesters (1-Short & 1-Long)(Korea)
• 00810000520077: Precision Probe Set for Gentle Pulse™ & Digitest™ Pulptesters (1-each Facial & Lingual Probe