RIGIFLEX II

GUDID 08714729719113

Single Use Achalasia Ballon Dilator

BOSTON SCIENTIFIC CORPORATION

Gastrointestinal/biliary dilation balloon catheter
Primary Device ID08714729719113
NIH Device Record Keybd16ec6a-f335-4b30-b927-7cef11f71df0
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIGIFLEX II
Version Model NumberM00554510
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 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 Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729719113 [Primary]

FDA Product Code

PIDesophageal dilator balloon with or without electrode sensors

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-13
Device Publish Date2016-09-24

On-Brand Devices [RIGIFLEX II]

08714729719120Single Use Achalasia Ballon Dilator
08714729719113Single Use Achalasia Ballon Dilator
08714729719106Single Use Achalasia Ballon Dilator

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