XSTAT-30 GEN 2, Single Pack

NSN 6510-01-632-9440

XSTAT is a first-in-kind self-expanding wound dressing, FDA-cleared for rapid control of junctional and extremity wounds

XSTAT-30 GEN 2 nowcontains approximately 20% more mini sponges per device than the original XSTAT 30

Quantity:1Applicator (Each Applicator contains approximately 108 pellets)

Simplified Plunger Mechanism - Two-Piece Design

Better Tip - More durable vinyl tip

Clear Packaging -XSTAT 30 GEN 2 packaging features a clear inner package versus the white inner package of the XSTAT 30

Size and Weight - Decreased 6%

Indications For Use:

XSTAT-30 GEN 2 is a hemostatic device for the control of severe, life-threateningbleeding from junctional wounds in the groin or axilla not amenable totourniquet application in adults and adolescents.XSTAT is a temporary device for use up to four (4) hours until surgicalcare is acquired. XSTAT should only be used for patients at high risk forimmediate life-threatening bleeding from, hemodynamically significant(Advanced Trauma Life Support class 3 or 4 hemorrhagic shock),non-compressible junctional wounds, and when definitive care at anemergency care facility cannot be achieved within minutes.

XSTAT is NOT indicated for use in: the thorax; the pleural cavity; themediastinum; the abdomen; the retroperitoneal space; the sacral spaceabove the inguinal ligament; or tissues above the clavicle.

ATTENTION: XSTAT contains rapidly expandingcellulose sponges coated with chitosan and individuallymarked with an X-shaped radiopaque marker.

***The XSTAT-30 GEN 2 device is designated as a "Prescription Only" device, to be used by physicians and / or trained medical professionals only***

Weight Individual package = 0.225 lbs. (102 gr)

Case of 10 units = 3 lbs (1.04 kg)

Volume Individual Package - 21 in3 (342 cm3)

Case of 10 units - 12x12x5 in (305x305x127 cm)

Patent Pending.

FDA

***The XSTAT device is designated as a "Prescription Only" device, to be used by physicians and / or trained medical professionals only***