Derma Sciences Canada Inc 97338 Bioguard Non-Adherent Dressings

Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, and cardiology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast.

SE CUTTING INSTRUMENT NO. 8

KIT, SMALL "E". Includes: 101 - BLOCK, BASALAR, 7” x 16” x 12” (00810050240987), 102 - HOLDER, ADULT AP-PA HEAD (00810050241205), 104 - BLOCK, PRESSURE, 5.5” x 7.38” x 10” (00810050241069), 128 – WEDGE, 3” x 10” x 10” (00810050240819), 129 – WEDGE, 4.63" x 10" x 10" (00810050240314), 130 – WEDGE, 10" x 10" x 10" (00810050240826), 131 – RECTANGLE, 4” x 10” x 10” (00810050241663), 136 – WEDGE, 2.25” x 8” x 10” (00810050240338), 138 – WEDGE, 3.75” x 8” x 10” (00810050240161), 140 – WEDGE, 6" x 10" x 10" (00810050240369)

Powder-free textured; The packages of proposed device including immediate package, middle box package and outer carton package.Immediate package quantity: 1 pairMiddle box package quantity: 50 pairsOuter carton package quantity: 400 pairs

2108 Series Sagittal Blade (28.9 x 0.64 x 58.7mm)

Precision Thin Offset (10.0 x 0.38 x 43.0mm)

Precision Thin (9.0 x 0.38 x 25.0mm)

X-Ray Detectable Sponge, Sterile, 4" x 4", 16-Ply, 10 per tray

K-WIRE TROCAR POINT BOTH ENDS .062 X 4

K-WIRE Trocar POINT BOTH ENDS .035 x 4

Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, and cardiology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast.

SE CUTTING INSTRUMENT NO. 8

KIT, SMALL "E". Includes: 101 - BLOCK, BASALAR, 7” x 16” x 12” (00810050240987), 102 - HOLDER, ADULT AP-PA HEAD (00810050241205), 104 - BLOCK, PRESSURE, 5.5” x 7.38” x 10” (00810050241069), 128 – WEDGE, 3” x 10” x 10” (00810050240819), 129 – WEDGE, 4.63" x 10" x 10" (00810050240314), 130 – WEDGE, 10" x 10" x 10" (00810050240826), 131 – RECTANGLE, 4” x 10” x 10” (00810050241663), 136 – WEDGE, 2.25” x 8” x 10” (00810050240338), 138 – WEDGE, 3.75” x 8” x 10” (00810050240161), 140 – WEDGE, 6" x 10" x 10" (00810050240369)

Powder-free textured; The packages of proposed device including immediate package, middle box package and outer carton package.Immediate package quantity: 1 pairMiddle box package quantity: 50 pairsOuter carton package quantity: 400 pairs