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 Instant Cath®	22112	FDA UDI	Class II	Active
MTG Cath-Lean®	42414	FDA UDI	Class II	Active
MTG Kiddie-Kath Paediatric	30508	FDA UDI	Class II	Active
MTG Pediatric Intermittent Catheter, Coude-tip	71610	FDA UDI	Class II	Active
MTG EZ-Advancer® Mini-Pak	42112	FDA UDI	Class II	Active
MTG Jiffy Cath™	20116	FDA UDI	Class II	Active
MTG EZ-Advancer®	32112	FDA UDI	Class II	Active
MTG Jiffy Cath® Soft / Coude	20712	FDA UDI	Class II	Active
MTG Soft Intermittent Catheter /Coude W/Indicator Line	81714	FDA UDI	Class II	Active
MTG Instant Cath® Coude	22614	FDA UDI	Class II	Active
MTG Intermittent Cathetter, Coude-tip with hydrophilic low-friction coating	81616	FDA UDI	Class II	Active
MTG EZ-Advancer®	32114	FDA UDI	Class II	Active
MTG Instant Cath® Coude	20614	FDA UDI	Class II	Active
MTG Cath-Lean®	42412	FDA UDI	Class II	Active
MTG Female Intermittent Catheter, Straight-tip with hydrophilic low-friction coa	81414	FDA UDI	Class II	Active
MTG Pediatric Intermittent Catheter, Straight-tip	71508	FDA UDI	Class II	Active
MTG Pediatric Intermittent Catheter, Straight-tip	71506	FDA UDI	Class II	Active
MTG Pediatric Intermittent Catheter, Coude-tip	71608	FDA UDI	Class II	Active
MTG Instant Cath® Mini-Pak	12114	FDA UDI	Class II	Active
MTG EZ-Gripper®	50112	FDA UDI	Class II	Active
MTG Jiffy Cath™	20114	FDA UDI	Class II	Active
MTG Kiddie-Kath® Paediatric	30108	FDA UDI	Class II	Active
MTG Cath-Lean®	40414	FDA UDI	Class II	Active
MTG Jiffy Cath® Soft / Coude	20716	FDA UDI	Class II	Active
MTG Intermittent Cathetter, Coude-tip with hydrophilic low-friction coating	81614	FDA UDI	Class II	Active
MTG Kiddie-Kath®	32508	FDA UDI	Class II	Active
Mtg Instant Cather (with And Without Kit), Mtg Instant Cath Deluxe (with And Without Kit)	K080878	FDA 510(k)	Class II	Active
Mmg Cath-N-Place	K873136	FDA 510(k)	Class II	Active
Mmg Foley Catheter	K840839	FDA 510(k)	Class II	Active
U-100 Bag	K821853	FDA 510(k)	Class II	Active
Mmg Delee Suction Catheter W/Mucous Trap	K871949	FDA 510(k)	Class I	Active
Oxygen Tubing	K840897	FDA 510(k)	Class I	Active
Exerciser, Resp., Deep Breathing	K780037	FDA 510(k)	Class II	Active
Readycath Catheter	K973120	FDA 510(k)	Class II	Active
Mmg Bile Bag	K911129	FDA 510(k)	Class II	Active
Mmg External Female Catheters	K854821	FDA 510(k)	Class II	Active
The Mmg Enteral Feeding Administration Set	K854660	FDA 510(k)	Class II	Active
U-200 Bag	K821854	FDA 510(k)	Class II	Active
Mli Set	K952392	FDA 510(k)	Class II	Active

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