Search Results

HEMOPORE® is intended for use in patients undergoing nasal/simus surgery as a temporary wound dressing. HEMOPORE® functions as a topical hemostatic aid to control mild bleeding by tamponade effect, blood absorption, platelet activation and aggregation. It acts as an adjunct to aid in the natural healing process as a space occupying stent to separate and support tissues. It prevents adhesions and minimizes edema.

HEMOPORE® is a sterile fragmentable nasal dressing of 8 cm composed of poly(DL-lactide-cos-caprolactone) urethane and blended with a chitosan derivate and a violet color additive. After insertion of HEMOPORE®in the nasal cavity, fluids will be absorbed by the dressing, which helps to control bleeding after surgery. The dressing fragments within several days by hydrolyzing ester bonds, whereafter it is drained from the nasal cavity via the natural mucus flow. The HEMOPORE® is sterilized in a blister package. The device is single-use, cannot be resterilized, and is a prescription product.

NASOPORE ® FD is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding following surgery or nasal trauma by tamponade effect and blood absorption.

NASOPORE "FD is composed of a bioresorbable poly(DL-lactide-co-s-caprolactone) urethane that fragments within several days after insertion in the nasal cavity, whereafter it is drained from the nasal cavity via the natural mucus flow. The NASOPORE® FD size and type are indicated on the label and are packed in a blister. NASOPORE "FD is indicated for single-use. The modification in this submission concerns a line extension to the predicate device NASOPORE "with a NASOPORE" FD that fragments faster than the cleared predicate device.

The Neurolac® nerve guide is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.

Neurolac® is designed to be a flexible and transparent resorbable poly(DL-lactide- co-e-caprolactone) tube to provide a protective environment for peripheral nerve reqeneration after injury and to create a conduit to quide axonal growth across a nerve gap. Neurolac® nerve guides are provided sterile in Tyvek pouch packages and retainer in a variety of sizes. The modification in this submission concerns a line extension to the predicate devices with a thinner wall thickness.

Nasopore® Ear is a fragmentable ear packing and is indicated for use in patients, undergoing ear surgery, as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding, following ear surgery, by tamponade effect and blood absorption.

Nasopore® Ear is composed of a bioresorbable poly(DL-lactide-co-s-caprolactone) urethane that fragments within several days after insertion in the outer and / or middle ear, whereafter it will fall out of the ear or leaves the body by the natural mucus flow. The type of Nasopore® Ear is indicated on the label. Nasopore® Ear is packed in a blister closed by a medical paper lid. Nasopore® Ear is indicated for single-use.

Nasopore® Ear is a fragmentable ear packing and is indicated for use in patients, undergoing outer ear surgery, as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding, following ear surgery, by tamponade effect and blood absorption.

Nasopore® Ear is composed of a bioresorbable poly(DL-lactide-co-sscription caprolactone) urethane that fragments within several days after insertion in the outer ear, whereafter it is drained from the cavity. The type of Nasopore® Ear is indicated on the label. Nasopore® Ear is packed in a blister closed by a medical paper lid. Nasopore® Ear is indicated for single-use.

Nasopore is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding following surgery or nasal trauma by tamponade effect and blood absorption.

Nasopore is composed of a fragmentable poly(DL-lactide-co-e-caprolactone) urethane that fragments within several days after insertion in the nasal cavity, whereafter it is drained from the nasal cavity via the natural mucus flow. The Nasopore size and type are indicated on the label and are packed in a Tyvek pouch. Nasopore is indicated for single-use.

The Neurolac nerve guide is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.

Neurolac® (4-10 mm) is designed to be a flexible and transparent resorbable poly(DL-lactide-co-s-caprolactone) tube to provide a protective environment for peripheral nerve regeneration, for nerves with an internal diameter ≤ 9.5 mm, after injury and to create a conduit to guide axonal growth across a nerve gap. Neurolac® (4-10mm) nerve guides are provided sterile in Tyvek pouch packages and retainer in a variety of sizes (4, 5, 6, 7, 8, 10 mm).

The VivoSorb Sheet is indicated for the use as a temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.

The VivoSorb Sheet is designed to be a flexible and transparent resorbable Device poly (DL-lactide-co-s-caprolactone) sheet to provide support to soft tissue Description where weakness exists. The VivoSorb Sheet is provided sterile in Tyvek pouch packages in a variety of sizes.

The Neurolac® nerve guide is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.

Neurolac® is designed to be a flexible and transparent resorbable poly(DL-lactide-co-ε-caprolactone) tube to provide a protective environment for peripheral nerve regeneration after injury and to create a conduit to guide axonal growth across a nerve gap. Neurolac® nerve guides are provided sterile in Tyvek pouch packages and retainer in a variety of sizes.