EXALT™

GUDID 08714729990956

Controller

BOSTON SCIENTIFIC CORPORATION

Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit
Primary Device ID08714729990956
NIH Device Record Key131813ed-bc1f-4587-a5da-d47a583006fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXALT™
Version Model NumberM0054243Z0
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729990956 [Primary]
GS108714729990956 [Primary]
GS108714729990956 [Primary]

FDA Product Code

FETEndoscopic video imaging system/component, gastroenterology-urology
FETEndoscopic video imaging system/component, gastroenterology-urology
FETEndoscopic video imaging system/component, gastroenterology-urology

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-19
Device Publish Date2019-12-23

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