Question 1

What types of medical devices does Premium Plus International Limited manufacture?

Accepted Answer

Premium Plus International Limited produces a range of medical devices primarily for dental and surgical use. Their portfolio includes single-use items like dental polishing cups, saliva absorbents, specimen container mailers, surgical/medical face masks, and non-sterile instrument drapes. They also manufacture reusable products such as instrument trays, sterilizer/disinfector rack inserts, and dental material application tools. These devices are designed to meet the needs of healthcare settings, ensuring functionality and compliance with relevant standards.

Question 2

Where is Premium Plus International Limited based?

Accepted Answer

Premium Plus International Limited is headquartered in the United States. This location allows the company to align its manufacturing and regulatory processes with U.S. standards, ensuring compliance with applicable guidelines for medical devices.

Question 3

Which regulatory registries list Premium Plus International Limited’s devices?

Accepted Answer

Premium Plus International Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices commercially distributed in the U.S., ensuring transparency and traceability for regulatory and market surveillance purposes.

Question 4

How are Premium Plus International Limited’s devices classified under FDA regulations?

Accepted Answer

Premium Plus International Limited’s devices fall into two primary classification categories under FDA regulations: Class I and Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body’s interaction with it.

Question 5

What distinguishes the reusable and single-use devices manufactured by Premium Plus International Limited?

Accepted Answer

Premium Plus International Limited’s reusable devices, such as instrument trays and sterilizer/disinfector rack inserts, are designed for repeated use in healthcare settings after proper cleaning, sterilization, or disinfection. In contrast, their single-use devices—like dental polishing cups, surgical masks, and non-sterile drapes—are intended for one-time use only to minimize infection risks and ensure hygiene. The distinction is based on their intended lifecycle, material composition, and regulatory requirements for safety and sterility.

Device	Model / Reference	Registries	Class	Status
Premium Plus	653-20BGE	FDA UDI	Class I	Active
Premium Plus	C3399-60R-261F	FDA UDI	Class I	Active
Premium Plus	B-WTS3399-60RA	FDA UDI	Class I	Active
Premium Plus	CS3399-105SP	FDA UDI	Class I	Active
Premium Plus	602-WHITE	FDA UDI	Class I	Active
Premium Plus	653-16-VA	FDA UDI	Class I	Active
Premium Plus	009	FDA UDI	Class I	Active
Premium Plus	CS3399-090RB	FDA UDI	Class I	Active
Premium Plus	107	FDA UDI	Class II	Active
Premium Plus	P222PK	FDA UDI	Class I	Active
Premium Plus International Limited	C01	FDA UDI	Class II	Active
Premium Plus	WT3399-60SA	FDA UDI	Class I	Active
Premium Plus	CTS3399-090RB	FDA UDI	Class I	Active
Premium Plus	199-2	FDA UDI	Class II	Active
Premium Plus	S901XL-IL	FDA UDI	Class I	Active
Premium Plus	C3399-60X-261F	FDA UDI	Class I	Active
Premium Plus	WT3399-105RL	FDA UDI	Class I	Active
Premium Plus	B-CT3399-090SP	FDA UDI	Class I	Active
Premium Plus	WS3399-60RA	FDA UDI	Class I	Active
Premium Plus	C3399-105SG	FDA UDI	Class I	Active
Premium Plus	1002-4	FDA UDI	Class I	Active
Premium Plus	657S-L	FDA UDI	Class I	Active
Premium Plus	WT3399-60WT	FDA UDI	Class I	Active
Pearson	140XS	FDA UDI	Class II	Active
Premium Plus	B-WS3399-60DB	FDA UDI	Class I	Active
Premium Plus	B-CT3399-090SG	FDA UDI	Class I	Active
Premium Plus	N050MIXB	FDA UDI	Class I	Active
Premium Plus	657S-BK	FDA UDI	Class I	Active
Premium Plus	B-CTS3399-090SP	FDA UDI	Class I	Active
Premium Plus	WT3399-090RB	FDA UDI	Class I	Active
Premium Plus	WT3399-105SG	FDA UDI	Class I	Active
Premium Plus	WTS3399-105RB	FDA UDI	Class I	Active
Premium Plus	W3399-60LV	FDA UDI	Class I	Active
Premium Plus	2288F4	FDA UDI	Class I	Active
Premium Plus	653-17BLUE	FDA UDI	Class I	Active
Premium Plus	651LBLUE	FDA UDI	Class I	Active
Premium Plus	2288F1	FDA UDI	Class I	Active
Premium Plus	C3399-60S-269A	FDA UDI	Class I	Active
Premium Plus	412	FDA UDI	Class I	Active
Premium Plus	902D	FDA UDI	Class I	Active
Premium Plus	FS2288P	FDA UDI	Class I	Active
Premium Plus	653-16LAV	FDA UDI	Class I	Active
Premium Plus	3225	FDA UDI	Class I	Active
Premium Plus	C3399-090SG	FDA UDI	Class I	Active
Premium Plus	2288TB	FDA UDI	Class I	Active
Premium Plus	S903-IY	FDA UDI	Class I	Active
Premium Plus	T-P222RA	FDA UDI	Class I	Active
Premium Plus	308-ASS	FDA UDI	Class I	Active
Premium Plus	B-WTS3399-60DB	FDA UDI	Class I	Active
Premium Plus	653-18GE	FDA UDI	Class I	Active

Premium Plus International Limited

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