"MH-405 FORCEPS SUCTION PLUG F/GIF-XT30"

"MH
Forceps Suction Plug (T-Plug) - MH-405

A non-sterile device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Ethylene Oxide
• High-level Disinfectant

Code: FBN

Device Name: Choledochoscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, accessories associated with choledochoscope

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).

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: instrument guided laparoscopically or through the esophagus into the biliary tree

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: bile ducts

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04953170069048

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A