Econolith EM1000

GUDID 07290016498363

MEDISPEC LTD.

Electromechanical lithotripsy system, extracorporeal
Primary Device ID07290016498363
NIH Device Record Key1fc9e79e-a38b-4ca6-a9a0-dc80e3708f15
Commercial Distribution StatusIn Commercial Distribution
Brand NameEconolith EM1000
Version Model NumberSW-8-A999d
Company DUNS600300909
Company NameMEDISPEC LTD.
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 Datetrue
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
GS107290016498363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNSLithotriptor, Extracorporeal Shock-Wave,Urological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-10
Device Publish Date2018-08-08

On-Brand Devices [Econolith EM1000]

07290016498394SW-8-A999r
07290016498387SW-8-A999q
07290016498370SW-8-A999m
07290016498363SW-8-A999d
07290016498356SW-8A999b

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