Egress Safety Catheter

GUDID 00850029182016

InnoCare Urologics, LLC

Indwelling urethral drainage balloon catheter, non-antimicrobial
Primary Device ID00850029182016
NIH Device Record Key0fdcd3c7-a9ec-4978-aa2c-3c044718dd93
Commercial Distribution StatusIn Commercial Distribution
Brand NameEgress Safety Catheter
Version Model NumberESC1610ST
Company DUNS117896929
Company NameInnoCare Urologics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Catheter Gauge16 French
Total Volume10 Milliliter
Catheter Gauge16 French
Total Volume10 Milliliter
Catheter Gauge16 French
Total Volume10 Milliliter
Catheter Gauge16 French
Total Volume10 Milliliter
Catheter Gauge16 French
Total Volume10 Milliliter
Catheter Gauge16 French
Total Volume10 Milliliter
Catheter Gauge16 French
Total Volume10 Milliliter
Catheter Gauge16 French
Total Volume10 Milliliter
Catheter Gauge16 French
Total Volume10 Milliliter
Catheter Gauge16 French
Total Volume10 Milliliter
Catheter Gauge16 French
Total Volume10 Milliliter
Catheter Gauge16 French
Total Volume10 Milliliter
Catheter Gauge16 French
Total Volume10 Milliliter
Catheter Gauge16 French
Total Volume10 Milliliter
Catheter Gauge16 French
Total Volume10 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850029182009 [Primary]
GS100850029182016 [Package]
Contains: 00850029182009
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZLCatheter, Retention Type, Balloon

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-27
Device Publish Date2025-03-19

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