Compliance EndoKit™ CEK-1028

GUDID 00840253119988

Compliance EndoKit

BOSTON SCIENTIFIC CORPORATION

Endoscopy preparation kit
Primary Device ID00840253119988
NIH Device Record Key1fd5a894-bdab-49f0-aea5-afd9cd57bf38
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompliance EndoKit™
Version Model NumberCEK-1028
Catalog NumberCEK-1028
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840253119919 [Primary]
GS100840253119988 [Package]
Contains: 00840253119919
Package: [20 Units]
In Commercial Distribution

FDA Product Code

MNLACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-23
Device Publish Date2018-11-05

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