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

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

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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).

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.

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

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