CaRi-Plaque

GUDID 05060737370000

CARISTO DIAGNOSTICS LIMITED

Clinical management support software
Primary Device ID05060737370000
NIH Device Record Keye8dcd5b6-6f1a-4c3f-afb0-b559a9a98bc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCaRi-Plaque
Version Model Number1.0
Company DUNS224183712
Company NameCARISTO DIAGNOSTICS LIMITED
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone203-889-5487
Emailinfo@caristo.com
Phone203-889-5487
Emailinfo@caristo.com
Phone203-889-5487
Emailinfo@caristo.com
Phone203-889-5487
Emailinfo@caristo.com
Phone203-889-5487
Emailinfo@caristo.com
Phone203-889-5487
Emailinfo@caristo.com
Phone203-889-5487
Emailinfo@caristo.com
Phone203-889-5487
Emailinfo@caristo.com
Phone203-889-5487
Emailinfo@caristo.com
Phone203-889-5487
Emailinfo@caristo.com
Phone203-889-5487
Emailinfo@caristo.com
Phone203-889-5487
Emailinfo@caristo.com
Phone203-889-5487
Emailinfo@caristo.com
Phone203-889-5487
Emailinfo@caristo.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105060737370000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-13
Device Publish Date2026-01-05

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