MTG Soft Intermittent Catheter, Straight-tip with hydrophilic low-friction coati

GUDID 20851593006238

Soft Intermittent Catheter, Straight-tip with hydrophilic coating

MEDICAL TECHNOLOGIES OF GEORGIA, INC.

Single-administration urethral catheterization kit, single-use
Primary Device ID20851593006238
NIH Device Record Key7f2b987c-dc55-4444-9b41-3ba9434d63f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMTG Soft Intermittent Catheter, Straight-tip with hydrophilic low-friction coati
Version Model Number81212
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 Gauge12 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
GS100851593006234 [Primary]
GS110851593006231 [Package]
Contains: 00851593006234
Package: [30 Units]
In Commercial Distribution
GS120851593006238 [Package]
Contains: 10851593006231
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 Soft Intermittent Catheter, Straight-tip with hydrophilic low-friction coati]

20851593006245Soft Intermittent Catheter, Straight-tip with hydrophilic coating
20851593006238Soft Intermittent Catheter, Straight-tip with hydrophilic coating

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