X-ray Beam Filter Kit 8154114

GUDID 60889978154111

4X4 X-ray Beam Filter Kit

CARESTREAM HEALTH, INC.

X-ray/radiation therapy beam filter, sheet
Primary Device ID60889978154111
NIH Device Record Keyc20fd719-97e0-4391-8c66-78c3b33264b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-ray Beam Filter Kit
Version Model NumberX-ray Beam Filter Kit
Catalog Number8154114
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS140889978154117 [Primary]
GS160889978154111 [Package]
Contains: 40889978154117
Package: Case [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPWDevice, beam limiting, x-ray, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

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