MTG Soft Intermittent Catheter /Coude W/Indicator Line

GUDID 20851593006498

Intermittent Catheter Coude-tip with hydrophilic low-friction coating and indicator line

MEDICAL TECHNOLOGIES OF GEORGIA, INC.

Single-administration urethral catheterization kit, single-use
Primary Device ID20851593006498
NIH Device Record Key321fcb42-d197-4ac0-89db-9b8b729dcb46
Commercial Distribution StatusIn Commercial Distribution
Brand NameMTG Soft Intermittent Catheter /Coude W/Indicator Line
Version Model Number81714
Company DUNS011005491
Company NameMEDICAL TECHNOLOGIES OF GEORGIA, 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

Customer Support Contacts

Phone770-788-0763
EmailMTGcustomerservice@medtechga.com

Device Dimensions

Catheter Gauge14 French

Operating and Storage Conditions

Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100851593006494 [Primary]
GS110851593006491 [Package]
Contains: 00851593006494
Package: [30 Units]
In Commercial Distribution
GS120851593006498 [Package]
Contains: 10851593006491
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GBMCatheter, Urethral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-25
Device Publish Date2019-01-25

On-Brand Devices [MTG Soft Intermittent Catheter /Coude W/Indicator Line]

20851593006504Intermittent Catheter Coude-tip with hydrophilic low-friction coating and indicator line
20851593006498Intermittent Catheter Coude-tip with hydrophilic low-friction coating and indicator line
20851593006481Intermittent Catheter Coude-tip with hydrophilic low-friction coating and indicator line

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