Uro-EZDilate KIT 18Fr (6mm) x 10cm URETERAL BALLOON DILATION CATHETER

GUDID 00821925033153

Gyrus Acmi, Inc.

Ureteral dilatation catheter
Primary Device ID00821925033153
NIH Device Record Key0eda9c0b-a378-4cc3-8da4-88bd32a8f7a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameUro-EZDilate KIT 18Fr (6mm) x 10cm URETERAL BALLOON DILATION CATHETER
Version Model NumberBURS0610K
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
GS100821925033153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KOEDILATOR, URETHRAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-05

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