EZDilate

GUDID 00821925042247

EZDilate - Wire Guided Esophageal / Pyloric / Colonic 3-Stage Balloon Dilatation Catheter 6mm / 7mm / 8mm

Gyrus Acmi, Inc.

Gastrointestinal/biliary dilation balloon catheter
Primary Device ID00821925042247
NIH Device Record Key66534ac5-ce63-4e43-952a-8694daabfa45
Commercial Distribution StatusIn Commercial Distribution
Brand NameEZDilate
Version Model NumberBD-420X-0855
Company DUNS007198742
Company NameGyrus Acmi, 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 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
GS100821925042247 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNQDilator, Esophageal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-02
Device Publish Date2024-07-25

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Trademark Results [EZDilate]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EZDILATE
EZDILATE
86353255 4767406 Live/Registered
OLYMPUS CORPORATION
2014-07-31

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