Gentle Pulse™ D636-K

GUDID 00810000520077

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

PARKELL, INC.

Dental pulp analysis system
Primary Device ID00810000520077
NIH Device Record Key7275b7d9-7734-4678-abb8-7d20ef60e354
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentle Pulse™
Version Model NumberD636-K
Catalog NumberD636-K
Company DUNS009900424
Company NamePARKELL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810000520077 [Primary]

FDA Product Code

EATTester, Pulp

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-22
Device Publish Date2021-12-10

On-Brand Devices [Gentle Pulse™]

M595D6360Precision Probe Set for Gentle Pulse™ & Digitest™ Pulptesters (1-each Facial & Lingual Probe
00810000520473Ground Clip and Lead Wire for Gentle Pulse™ & Digitest™ Pulptesters
00810000520466Ground Clip Lead Wire & Adaptor for Gentle Pulse™ & Digitest™ Pulptesters (Complies with New
00810000520459Metal Probes for Gentle Pulse™ & Digitest™ Pulptesters (1-Short & 1-Long)
00810000520442Gentle Pulse™ Pulp Vitality Tester
00810000520435Gentle Pulse™ Pulp Vitality Tester
M595D624MS0Gentle Pulse™ Pulp Vitality Tester
00810000520978Gentle Pulse™ Pulp Vitality Tester (Korea)
00810000520961Metal Probes for Gentle Pulse™ & Digitest™ Pulptesters (1-Short & 1-Long)(Korea)
00810000520077Precision Probe Set for Gentle Pulse™ & Digitest™ Pulptesters (1-each Facial & Lingual Probe

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