Question 1

What types of medical devices does Next Science LLC manufacture?

Accepted Answer

Next Science LLC specializes in wound care and surgical irrigation solutions. Their portfolio includes non-antimicrobial and antimicrobial wound irrigation solutions, some of which are sterile and formulated with multiple solutes. They also produce antimicrobial wound hydrogel dressings, available in both sterile and non-sterile versions, designed for surgical and post-operative wound management.

Question 2

Where is Next Science LLC based, and what regulatory regions do their devices cover?

Accepted Answer

Next Science LLC is based in the United States. Their devices are registered in the EU’s EUDAMED database, indicating compliance with European Union regulatory requirements. Additionally, they are listed in the FDA 510(k) and UDI registries, showing their devices have undergone the necessary FDA review processes for market authorization in the US.

Question 3

How are Next Science LLC’s devices classified under FDA regulations?

Accepted Answer

Next Science LLC’s devices fall under three FDA classification categories: Class II, which typically requires special controls to ensure safety and effectiveness; Class IIa, a subset of Class II with additional regulatory oversight; and Class U (Unclassified), indicating these devices are either exempt from classification or awaiting classification. Classification determines the regulatory pathway and scrutiny each device undergoes before authorization.

Question 4

Which regulatory databases list Next Science LLC’s devices?

Accepted Answer

Next Science LLC’s devices are documented in two key regulatory databases: EUDAMED, the European Union’s medical device registry, and the FDA’s 510(k) and UDI registries, which track cleared devices and their unique identifiers in the US. These listings reflect compliance with respective regional requirements for market authorization.

Device	Model / Reference	Registries	Class	Status
Bactisure™	00-8887-001-00	FDA UDI	Class II	Active
Xperience	MC-SL-0005-4D	FDA UDI	U	Active
BlastX™	MC-WG-0003-12	FDA UDI	U	Active
Xperience	MC-SL-0005-4	FDA UDI	U	Active
BIOWASH Surgical Irrigation	BW0500-4	FDA UDI	U	Active
BlastX™	MC-WG-0003-80	FDA UDI	U	Active
BlastX™	MC-WG-0003-40	FDA UDI	U	Active
BlastX™	WG-0001	FDA UDI	U	Active
BIOWASH Surgical Irrigation	BW0500	FDA UDI	U	Active
Xperience	MC-SL-0005-1D	FDA UDI	U	Active
Xperience	MC-SL-0005-10D	FDA UDI	U	Active
TridentX	MC-WW-0005-320	FDA UDI	U	Active
Xperience	MC-SL-0005-10	FDA UDI	U	Active
SurgX™	MC-WG-0010-8	FDA UDI	U	Active
BlastX™	MC-WG-0011-30	FDA UDI	U	Active
Siteguard	MC-SL-0008-10	FDA UDI	U	Unknown
BlastX	WG-0003	FDA UDI	U	Active
Next Science Wound Gel	K150792	FDA 510(k)	U	Active
TorrentX Wound Wash	K203446	FDA 510(k)	U	Active
Next Science Irrigation Solution	K161165	FDA 510(k)	Class II	Active
MIS Solution	K203835	FDA 510(k)	U	Active
Next Science Wound Gel (Rx)	K163188	FDA 510(k)	U	Active
Bactisure Wound Lavage	SL-0002	EUDAMEDFDA UDI	Class IIa	Active

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