- Physicians Office Resource

14MM OBTURATOR ASSY
Welch Allyn, Inc. - 901117

Device Description

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through relayed lens optics or direct vision. This device is typically used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. This is a reusable device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: FER

Device Name: Anoscope And Accessories

Device Class: 2

Physical State: endoscope, accessories associated with anoscope such as mini-scope

Definition: To examine and perform procedures within the anus and rectum.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Instrument inserted through anus into rectum

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: anus and rectum

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Identifiers

Device Id: 00732094007602

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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