Lux 35 Detector AK7294

GUDID 60889975950570

PACKED, LUX 35 DETECTOR, 3543

CARESTREAM HEALTH, INC.

Indirect flat panel x-ray detector
Primary Device ID60889975950570
NIH Device Record Key8cd590a5-fec7-45a9-bc88-05d6724955a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameLux 35 Detector
Version Model NumberLux 35 Detector
Catalog NumberAK7294
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
GS160889975950570 [Primary]

FDA Product Code

MQBSolid state x-ray imager (flat panel/digital imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-07
Device Publish Date2021-08-30

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