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510(k) Data Aggregation
(269 days)
Over the counter:
Ganymede and Ganymede-X are intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
Prescription Use:
Ganymede and Ganymede-X are intended to be used as a hemostatic dressing for local temporary management of moderately to severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological), including junctional wounds not amenable to tourniquet use and traumatic injuries
Ganymede is a non-woven fabric comprised of carboxymethyl cellulose fibers, calcium alginate fibers containing Purified clinoptilolite tuff and Lyocell fibers. The Ganymede and Ganymede-X dressings are intended to be used as hemostatic dressings for local temporary management of traumatic injuries and severely and moderately bleeding wounds. The Ganymede-X dressing incorporates a strip of Micropake radiopaque yarn that has been stitch bonded to the fabric to aid identification under X-Ray. The devices are free from animal derived materials, non-exothermic, fast acting and highly absorbent. The mechanism of action is provided by the absorbent nature of the dressing components and the high calcium ion concentration.
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