CS 2200 5153598

GUDID 60192155153594

CS 2200 110V/205CM LONG WALL MTD

CARESTREAM DENTAL LLC

Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital
Primary Device ID60192155153594
NIH Device Record Keyb7e67e39-2590-4928-965a-468fd680da68
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS 2200
Version Model NumberCS 2200
Catalog Number5153598
Company DUNS019796106
Company NameCARESTREAM DENTAL LLC
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
GS160192155153594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EHDUNIT, X-RAY, EXTRAORAL WITH TIMER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-06-07
Device Publish Date2018-01-15

On-Brand Devices [CS 2200]

60192155153617CS 2200 110V/170CM SHORT WALL MTD
60192155153600CS 2200 110V/188CM STD WALL MTD
60192155153594CS 2200 110V/205CM LONG WALL MTD
60192155153587CS 2200 230V/170CM SHORT WALL MTD
60192155153570CS 2200 230V/188CM STD WALL MTD
60192155153563CS 2200 230V/205CM LONG WALL MTD

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