Question 1

What types of medical devices does Medical Technologies of Georgia primarily manufacture?

Accepted Answer

Medical Technologies of Georgia specializes in single-use urethral catheterization kits and related accessories. Their portfolio includes intermittent catheters (both straight-tip and coude-tip designs) for adults, adolescents, and pediatric patients, as well as catheter holders and specialized kits like the EZ-Advancer series and Jiffy Cath variants. These devices are designed for intermittent catheterization, ensuring ease of use and patient comfort.

Question 2

Where is Medical Technologies of Georgia based, and how does that affect its regulatory compliance?

Accepted Answer

Medical Technologies of Georgia is based in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations. The company’s products are listed in the FDA’s 510(k) and UDI registries, reflecting compliance with U.S. medical device requirements. The FDA classifies these devices as either Class I or Class II, depending on their risk level and intended use.

Question 3

Which regulatory registries list Medical Technologies of Georgia’s devices?

Accepted Answer

Medical Technologies of Georgia’s devices are included in the FDA’s official registries: the 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries track devices that require 510(k) clearance or fall under UDI requirements, ensuring transparency and compliance with U.S. medical device regulations.

Question 4

How are Medical Technologies of Georgia’s devices classified by the FDA, and why does this matter?

Accepted Answer

Medical Technologies of Georgia’s devices are classified as either Class I or Class II by the FDA. Class I devices generally pose the lowest risk and may have fewer regulatory controls, while Class II devices require special controls to ensure safety and effectiveness. This classification determines the level of oversight, reporting requirements, and regulatory pathways (such as 510(k) clearance) that apply to each product.

Question 5

What distinguishes Medical Technologies of Georgia’s catheter products from others in the market?

Accepted Answer

Medical Technologies of Georgia’s catheter products are designed with specific patient needs in mind, including pediatric, adolescent, and adult sizes, as well as specialized features like hydrophilic low-friction coatings and coude-tip designs for easier insertion. Their EZ-Advancer and Jiffy Cath series are engineered for simplicity and efficiency, catering to both clinical and home-use scenarios. These distinctions help address varied patient requirements while maintaining compliance with regulatory standards.

Device	Model / Reference	Registries	Class	Status
MTG EZ-Advancer® Mini-Pak	42116	FDA UDI	Class II	Active
MTG EZ-Advancer Adolescent	30510	FDA UDI	Class II	Active
MTG Jiffy Cath™	22116	FDA UDI	Class II	Active
MTG EZ-Advancer® Soft	31214	FDA UDI	Class II	Active
MTG Intermittent Catheter, Straight-tip	71116	FDA UDI	Class II	Active
MTG Instant Cath®	22114	FDA UDI	Class II	Active
MTG Pediatric Intermittent Catheter, Straight-tip	71510	FDA UDI	Class II	Active
MTG Pediatric Intermittent Catheter, Straight-tip with hydrophilic low-friction	81108	FDA UDI	Class II	Active
MTG EZ-Advancer®	31112	FDA UDI	Class II	Active
MTG Eagle Board	100	FDA UDI	Class I	Active
MTG Jiffy Cath® Soft / Coude	20714	FDA UDI	Class II	Active
MTG Intermittent Catheter, Coude-tip	71616	FDA UDI	Class II	Active
MTG Instant Cath® Soft / Coude	22714	FDA UDI	Class II	Active
MTG Instant Cath® Coude	22616	FDA UDI	Class II	Active
MTG Instant Cath® Mini-Pak	20114	FDA UDI	Class II	Active
MTG EZ-Gripper® Long	52816	FDA UDI	Class II	Active
MTG EZ-Advancer® Soft	31212	FDA UDI	Class II	Active
MTG EZ-Advancer®	30112	FDA UDI	Class II	Active
MTG Jiffy Cath™	21114	FDA UDI	Class II	Active
MTG Soft Intermittent Catheter /Coude W/Indicator Line	81716	FDA UDI	Class II	Active
MTG EZ-Advancer®	31114	FDA UDI	Class II	Active
MTG EZ-Advancer®	31110	FDA UDI	Class II	Active
MTG Jiffy Cath™ Coude	22616	FDA UDI	Class II	Active
MTG Pediatric Intermittent Catheter, Straight-tip with hydrophilic low-friction	81110	FDA UDI	Class II	Active
MTG EZ-Advancer®	30114	FDA UDI	Class II	Active
MTG Jiffy Cath™ Coude	22612	FDA UDI	N/A	Active
MTG Jiffy Cath® Mini-Pak	10116	FDA UDI	Class II	Active
MTG Instant Cath® Soft /Coude	22716	FDA UDI	Class II	Active
MTG EZ-Advancer® Soft	30212	FDA UDI	Class II	Active
MTG Intermittent Catheter, Coude-tip	71612	FDA UDI	Class II	Active
MTG EZ-Advancer®	30116	FDA UDI	Class II	Active
MTG EZ-Gripper®	52116	FDA UDI	Class II	Active
MTG Instant Cath® Mini-Pak	12112	FDA UDI	Class II	Active
MTG Jiffy Cath™	22112	FDA UDI	Class II	Active
MTG Intermittent Catheter, Straight-tip	71112	FDA UDI	Class II	Active
MTG Pediatric Intermittent Catheter , Coude-tip with hydrophilic low-friction co	81610	FDA UDI	Class II	Active
MTG Jiffy Cath® Mini-Pak	10114	FDA UDI	Class II	Active
MTG EZ-Gripper® Long	52812	FDA UDI	Class II	Active
MTG EZ-Advancer®	32510	FDA UDI	Class II	Active
MTG Jiffy Cath™	22114	FDA UDI	Class II	Active
MTG EZ-Advancer® Mini-Pak	40116	FDA UDI	Class II	Active
MTG Jiffy Cath™ Coude	20612	FDA UDI	Class II	Active
MTG Soft Intermittent Catheter, Straight-tip with hydrophilic low-friction coati	81214	FDA UDI	Class II	Active
MTG Jiffy Cath® Mini-Pak	10112	FDA UDI	Class II	Active
MTG EZ-Advancer®	32116	FDA UDI	Class II	Active
MTG EZ-Advancer® Adolescent	30110	FDA UDI	Class II	Active
MTG Jiffy Cath™	20112	FDA UDI	Class II	Active
MTG Soft Intermittent Catheter, Straight-tip	71214	FDA UDI	Class II	Active
MTG Jiffy Cath™ Coude - PVP kit	21614	FDA UDI	Class II	Active
MTG Cath-Lean®	40412	FDA UDI	Class II	Active

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