Integra LifeSciences Corporation

Catalogue No. MIDRT 8101 Lot No. 105A00324750

General and Plastic Surgery Devices

3

Yes

Nationwide Distribution to PA

Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only || Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound. Integra template is indicated for the postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. Integra template is also indicated for the repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient || Manufactured by: || Integra LifeSciences Corporation || 311 Enterprise Drive, Plainsboro, NJ 08536 || 877-444-1122 USA n 609-936-5400 outside USA || 866-800-7742 fax

All lot numbers from 2002 to current

Neurological Devices

2

No

Worldwide distribution: USA (Nationwide) and countries of: Argentina, Australia, Belgium, Canada, China, Czec, Denmark, France, Hong Kong, Hungary, Italy, Japan, Malaysia, Philippines, Singapore, Spain, South Africa, and UK.

Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts || The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes

All lot numbers from 2002 to current

Neurological Devices

2

No

Worldwide distribution: USA (Nationwide) and countries of: Argentina, Australia, Belgium, Canada, China, Czec, Denmark, France, Hong Kong, Hungary, Italy, Japan, Malaysia, Philippines, Singapore, Spain, South Africa, and UK.

Integra HRAIM Head Ring Assembly with Intubation Mounts || The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes

1105457 1112377, 1112378 1112103 1112106, 1112003,  1112296, 1110715 1112052, 1112004,  1112030 1111972 1112376

Neurological Devices

2

Yes

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

NeuraGen Nerve Guide || NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

1125807, 1125802, 1125806, 1125804, 1125808, 1111845, 1125805, 1125803, 1125809,  1125810,  1130069, 1130061, 1130064, 1130065, 1130417,  1130521,  1110850, 1111839, 1111621, 1110274, 1105302, 1110669, 1111618, 1112228, 1110160, 1110670, 1111606, 1111616, 1104916, 1111614, 1111615, 1110273, 1111277, 1111849, 1110667, 1104918, 1110853, 1111619, 1111842, 1110666, 1112109, 1112108, 1104917, 1110854, 1111620, 1110276, 1105301, 1111846, 1112225, 1110851, 1111617, 1105303, 1110852, 1110270, 1105304, 1110246, 1112222, 1112224, 1110245, 1111844, 1111850, 1110668, 1125522, 1125628, 1104879, 1110814, 1111610, 1125525, 1104876, 1110815, 1111607, 1125526

Neurological Devices

2

Yes

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

Dural Graft Matrix || DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..