MTG Intermittent Cathetter, Coude-tip with hydrophilic low-friction coating

GUDID 20851593006344

Intermittent Catheter Coude-tip with hydrophilic coating

MEDICAL TECHNOLOGIES OF GEORGIA, INC.

Single-administration urethral catheterization kit, single-use
Primary Device ID20851593006344
NIH Device Record Key9ea1bf5b-b7e9-4f03-b9c5-8fa0b10dc4d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMTG Intermittent Cathetter, Coude-tip with hydrophilic low-friction coating
Version Model Number81616
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 Gauge16 French

Operating and Storage Conditions

Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100851593006340 [Primary]
GS110851593006347 [Package]
Contains: 00851593006340
Package: [30 Units]
In Commercial Distribution
GS120851593006344 [Package]
Contains: 10851593006347
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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-13

On-Brand Devices [MTG Intermittent Cathetter, Coude-tip with hydrophilic low-friction coating]

20851593006344Intermittent Catheter Coude-tip with hydrophilic coating
20851593006320Intermittent Catheter Coude-tip with hydrophilic coating

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