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

GUDID 20851593006160

Pediatric Intermittent Catheter, Straight-tip with hydrophilic coating

MEDICAL TECHNOLOGIES OF GEORGIA, INC.

Single-administration urethral catheterization kit, single-use
Primary Device ID20851593006160
NIH Device Record Key64f4e43d-87fd-450e-9523-e90e1b534ba9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMTG Pediatric Intermittent Catheter, Straight-tip with hydrophilic low-friction
Version Model Number81108
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 Gauge8 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
GS100851593006166 [Primary]
GS110851593006163 [Package]
Contains: 00851593006166
Package: [30 Units]
In Commercial Distribution
GS120851593006160 [Package]
Contains: 10851593006163
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 Pediatric Intermittent Catheter, Straight-tip with hydrophilic low-friction ]

20851593006184Pediatric Intermittent Catheter, Straight-tip with hydrophilic coating
20851593006160Pediatric Intermittent Catheter, Straight-tip with hydrophilic coating

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