Question 1

What does Steripack USA (Limited) LLC manufacture?

Accepted Answer

Steripack USA (Limited) LLC manufactures single-use absorbent tip applicators and swabs, including polyester spun swabs, foam swabs with colored handles, and flocked swabs, as well as Hu antibody (anti-Hu) IVD kits using fluorescent immunoassay technology, based solely on the provided device data.

Question 2

Where is Steripack USA (Limited) LLC based?

Accepted Answer

Steripack USA (Limited) LLC is based in the United States, as explicitly stated in the country field of the device data.

Question 3

Which regulatory registries list devices from Steripack USA (Limited) LLC?

Accepted Answer

Devices from Steripack USA (Limited) LLC are listed in the FDA's Unique Device Identification (FDA UDI) system, as indicated by the 'LISTED IN: fda_udi' field in the provided data.

Question 4

How are the devices manufactured by Steripack USA (Limited) LLC classified?

Accepted Answer

The devices manufactured by Steripack USA (Limited) LLC are classified as Class I medical devices, as specified in the 'DEVICE CLASSES: Class I' field of the device data.

Device	Model / Reference	Registries	Class	Status
Polyester Spun Swab 28 Ct. Pouch	60595	FDA UDI	Class I	Active
Sterile Polyester Spun Swab 10 Pack	60578	FDA UDI	Class I	Active
Sterile 3" Foam swab with yellow handle V2 100ct.	60652	FDA UDI	Class I	Active
Sterile Polyester Spun Swab	60564	FDA UDI	Class I	Active
Sterile 3” Sterile Flocked Swab with blue handle	60614	FDA UDI	Class I	Active
Sterile Polyester Spun Swab 20 Pack	60589	FDA UDI	Class I	Active
Polyester Spun Swab 500ct. Pouch	60616	FDA UDI	Class I	Active
Sterile Polyester Spun Swab 25 Pack	60566	FDA UDI	Class I	Active
Sterile Narrow Polyester Spun Swab V2 25 Pack	60580	FDA UDI	Class I	Active
Sterile Polyester Spun Swab 25 Ct. Pouch	60594	FDA UDI	Class I	Active
Polyester Spun Swab 25ct. Pouch	60626	FDA UDI	Class I	Active
XpressCollect TM Sterile Polyester Spun Swab in Tube 1 ea.	60600	FDA UDI	Class I	Active
XpressCollect TM Sterile Polyester Spun Swab in Tube 100 ea.	60601	FDA UDI	Class I	Active
Sterile Narrow Polyester Spun Swab V2	60577	FDA UDI	Class I	Active
Sterile 3” Foam Swab with yellow handle V2	60612	FDA UDI	Class I	Active
Sterile 3” Sterile Flocked Swab with white handle	60615	FDA UDI	Class I	Active
Sterile Narrow Polyester Spun Swab 25 Pack	60579	FDA UDI	Class I	Active
Sterile Narrow Polyester Spun Swab	60567	FDA UDI	Class I	Active
Polyester Spun Swab 200 Ct. Pouch	60596	FDA UDI	Class I	Active
Polyester Spun Swab 4 Ct. Pouch	60598	FDA UDI	Class I	Active
Polyester Spun Swab 50ct. Pouch	60632	FDA UDI	Class I	Active

STERIPACK USA (LIMITED) LLC

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