MTG Intermittent Catheter, Coude-tip

GUDID 20851593006276

Intermittent Catheter, Coude-tip

MEDICAL TECHNOLOGIES OF GEORGIA, INC.

Single-administration urethral catheterization kit, single-use
Primary Device ID20851593006276
NIH Device Record Key01fcd7d6-6812-4ca4-be01-54a4d5add3c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMTG Intermittent Catheter, Coude-tip
Version Model Number71612
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

Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature not to exceed 120 degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature not to exceed 120 degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100851593006272 [Primary]
GS110851593006279 [Package]
Contains: 00851593006272
Package: [30 Units]
In Commercial Distribution
GS120851593006276 [Package]
Contains: 10851593006279
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

Devices Manufactured by MEDICAL TECHNOLOGIES OF GEORGIA, INC.

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10851593006750 - MTG Jiffy Cath™ Mini-Pak2019-09-18 Pre-Lubricated Closed System Intermittent Catheter
10851593006767 - MTG Jiffy Cath™ Mini-Pak2019-09-18 Pre-Lubricated Closed System Intermittent Catheter
10851593006774 - MTG Jiffy Cath™ Mini-Pak2019-09-18 Pre-Lubricated Closed System Intermittent Catheter
10851593006781 - MTG Jiffy Cath™2019-09-18 Pre- Lubricated Closed System Intermittent Catheter
10851593006798 - MTG Jiffy Cath™2019-09-18 Pre-Lubricated Closed System Intermittent Catheter
10851593006804 - MTG Jiffy Cath™2019-09-18 Pre-Lubricated Closed System Intermittent Catheter
10851593006811 - MTG Jiffy Cath™ Coude2019-09-18 Pre-Lubricated Closed System Intermittent Catheter

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