MTG Intermittent Catheter, Straight-tip with hydrophilic low-friction coating

GUDID 20851593006177

Intermittent Catheter, Straight-tip with hydrophilic coating

MEDICAL TECHNOLOGIES OF GEORGIA, INC.

Single-administration urethral catheterization kit, single-use
Primary Device ID20851593006177
NIH Device Record Key1cd6ac8c-d13a-48ff-b398-bf4ae50edd53
Commercial Distribution StatusIn Commercial Distribution
Brand NameMTG Intermittent Catheter, Straight-tip with hydrophilic low-friction coating
Version Model Number81114
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
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100851593006173 [Primary]
GS110851593006170 [Package]
Contains: 00851593006173
Package: [30 Units]
In Commercial Distribution
GS120851593006177 [Package]
Contains: 10851593006170
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 Catheter, Straight-tip with hydrophilic low-friction coating]

20851593006207Intermittent Catheter, Straight-tip with hydrophilic coating
20851593006177Intermittent Catheter, Straight-tip with hydrophilic coating

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.