Question 1

What types of medical devices does AMD Medicom Inc manufacture?

Accepted Answer

AMD Medicom Inc specializes in single-use medical textiles and protective barriers. Their product range includes surgical and isolation gowns, non-antimicrobial face masks, nitrile examination gloves (non-powdered), sterilization packaging, radiopaque surgical sponges, and various gauze pads for wound care and procedural use. These items are designed for clinical, surgical, and examination settings to ensure patient and staff safety.

Question 2

Where is AMD Medicom Inc based?

Accepted Answer

AMD Medicom Inc is headquartered in the United States. While the exact location isn’t specified, the company operates within the U.S. regulatory framework, which governs its medical device portfolio.

Question 3

Which regulatory registries list AMD Medicom Inc’s devices?

Accepted Answer

AMD Medicom Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. medical device regulations by assigning a standardized identifier to each product, helping track devices throughout their lifecycle.

Question 4

How are AMD Medicom Inc’s devices classified under U.S. regulations?

Accepted Answer

AMD Medicom Inc’s devices fall under FDA’s Class I and Class II categories, with some classified as unlisted (U). Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The unlisted (U) classification indicates devices not previously cleared or approved, requiring additional review.

Device	Model / Reference	Registries	Class	Status
Medicom Safewear	8101-C	FDA UDI	Class I	Active
Medicom AssureTouch	9990-C	FDA UDI	Class I	Active
Medicom Assuremask Balance	205615	FDA UDI	Class II	Active
Medicom Assuremask Valiant	205715	FDA UDI	Class II	Active
Medicom AssureTouch	9998-C	FDA UDI	Class I	Active
Ocean Pacific	1226-A	FDA UDI	Class I	Active
Amd-Ritmed All Gauze	B3312	FDA UDI	Class I	Active
Medicom Denticare Pro-Polish	10047-FBG	FDA UDI	Class I	Active
Steril Peel	221636	FDA UDI	Class II	Active
Medicom Distech	7286	FDA UDI	Class I	Active
Amd-Ritmed All Gauze	B3005	FDA UDI	Class I	Active
Medicom SafeTouch	1129-B	FDA UDI	Class I	Active
Medicom AssureTouch	9970-SP6	FDA UDI	Class I	Active
Hedy Dental Dam	310DB-6H	FDA UDI	Class I	Active
Amd-Ritmed All Gauze	B3120	FDA UDI	Class I	Active
Amd-Ritmed All Gauze	6008	FDA UDI	Class I	Active
Ocean Pacific	OPXS-BL2	FDA UDI	Class I	Active
Generic	561218	FDA UDI	Class II	Active
Amd-Ritmed Solon Purfybr	4002D	FDA UDI	Class I	Active
Medicom Safetouch	1266TG	FDA UDI	Class I	Unknown
Medicom Safebasics	8019	FDA UDI	Class I	Active
Medicom Safebasics	8004	FDA UDI	Class I	Active
Medicom Safemask Tailormade	2070	FDA UDI	Class II	Active
Medicom Safetouch	1266MG	FDA UDI	Class I	Unknown
Steril Peel	221434RXEU	FDA UDI	Class II	Active
AMD Ritmed AssureWear VersaGown	K190306	FDA 510(k)	Class II	Active
Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)	K190308	FDA 510(k)	Class II	Active

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