MTG Soft Intermittent Catheter, Straight-tip

GUDID 20851593006153

Soft Intermittent Catheter, Straight-tip

MEDICAL TECHNOLOGIES OF GEORGIA, INC.

Single-administration urethral catheterization kit, single-use
Primary Device ID20851593006153
NIH Device Record Key4ec9e1cf-7ffe-42e0-ae7a-869743b971c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameMTG Soft Intermittent Catheter, Straight-tip
Version Model Number71216
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

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
GS100851593006159 [Primary]
GS110851593006156 [Package]
Contains: 00851593006159
Package: [30 Units]
In Commercial Distribution
GS120851593006153 [Package]
Contains: 10851593006156
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]

20851593006153Soft Intermittent Catheter, Straight-tip
20851593006146Soft Intermittent Catheter, Straight-tip
20851593006139Soft Intermittent Catheter, Straight-tip

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