Sterilization Methods: Ethylene OxideHigh-level DisinfectantMoist Heat or Steam SterilizationEthylene OxideHigh-level DisinfectantMoist Heat or Steam Sterilization

Definition: to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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If you're wanting to create a custom design for your Hardcover Photo Book dust jacket, below are the dimensions you can use in a third party editor.

Be sure to add extra space to each edge of your design, to account for the trim zone. We recommend adding .125 to each of the 4 sides of a custom design (or .25 to each dimension number) to account for the trim zone. For example, if you're creating a design that is 18.25x9, we would recommend that the designed file size be 18.5x9.25.

When you're in the editor view, you can click 'layouts' under the Hardcover Photo Book. In the layouts tab, you will see all of the available dust jacket designs. Each dust jacket has a different title. The dimensions below are listed as either "Two Image Layout" or "Full Bleed Layout", which include most of the options you see listed in the editor.

Finally, be sure to always email yourself a PDF proof before placing your order. The PDF proof is the most accurate proof in our system, and can be sent straight to your inbox from the editor. You can email yourself a PDF preview of your project by clicking the three dots icon in the top of the editor, then selecting "Email PDF Proof". Once you see the message: "Your Proofs are Being Processed", you're good to go!

Code: FBNDevice Name: Choledochoscope And Accessories, Flexible/RigidDevice Class: 2Physical State: endoscope, accessories associated with choledochoscopeDefinition: to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).Submission Type ID: 1Review Panel: GUReview Code: N/ATechnical Method: NGmp Exempt Flag: instrument guided laparoscopically or through the esophagus into the biliary treeLife Sustain Support Flag: NUnclassified Reason: N/AImplant Flag: NTarget Area: bile ductsRegulation Number: 876.1500Third Party Flag: NMedical Specialty: GU

A device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a reusable device.

The dimensions below are listed in inches. The "Two Image Layout" option is listed with the Back Cover Image first, and the Front Cover Image second (Back Cover Image WxH, Front Cover Image WxH). For example: 9.125x9, 9.6875x9 = 9.125 inches wide and 9 inches tall for the Back Cover Image, 9.6875 inches wide x 9 inches tall for the Front Cover Image.

"Paper Dimensions" are listed the total dimensions of the dust jacket piece of paper, including the white flaps on the left and right side that cannot be customized.

Please keep in mind that our editor was not built for custom layouts, the system works best when you utilize the designs in the editor (in the "layouts" tab). That being said, we are thrilled that some customers can create their own layouts, but it is a bit more of a "trial and error" process rather than a perfect system. The information below will guide you through the best steps to create a custom design for a dust jacket.

You can customize the back cover, the front cover, and the spine. There are white spaces on the left and right ends of the dust jacket that wrap around the cover of the book (the interior flaps), these cannot be edited or adjusted in any way, and will be white. The customizable/printed dimensions are listed below, and these will wrap around the edges of the book just slightly so the white flaps don't show when the book is closed. You cannot customize the inside flaps of the dust jacket, only the front and back covers, and spine.

Device Sterile: FalseSterilization Prior To Use: TrueSterilization Methods: Ethylene OxideHigh-level DisinfectantMoist Heat or Steam SterilizationEthylene OxideHigh-level DisinfectantMoist Heat or Steam Sterilization

Device Id: 04953170063114Device Type: PrimaryDeviceId Issuing Agency: GS1Contains DI Number: N/APackage Quantity: N/APackage Discontinue Date: N/APackage Status: N/APackage Type: N/A