CS 1600 9G1174

GUDID 60889974007909

Handpiece, Wired, 1600

CARESTREAM HEALTH, INC.

Dental caries detector, optical induced fluorescence
Primary Device ID60889974007909
NIH Device Record Key0200c53c-451a-4f6e-8cc8-5268959a1a0d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS 1600
Version Model NumberCS 1600
Catalog Number9G1174
Company DUNS793169512
Company NameCARESTREAM HEALTH, 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS160889974007909 [Primary]

FDA Product Code

NBLLaser,fluorescence caries detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-16

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