- Physicians Office Resource

GUIDING SHEATH FOR LTF 10MM SCOPE 160MM - MAJ-2023

Device Description

A component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

Moist Heat or Steam Sterilization

Ethylene Oxide

High-level Disinfectant

Moist Heat or Steam Sterilization
Ethylene Oxide
High-level Disinfectant

Product Codes

Code: NWV

Device Name: Laparoscopic Accessories, Gynecologic

Device Class: 1

Physical State: Metal instruments

Definition: Exempt laparoscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Submission Type ID: 4

Review Panel: OB

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Part of a system where the accessories advance the working channel of the laparoscope to perform it's function.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Abdominal cavity.

Regulation Number: 884.1720

Third Party Flag: N

Medical Specialty: OB

Device Identifiers

Device Id: 04953170332838

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

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