- Physicians Office Resource

DISPOSABLE ANO SHELF BOX
Welch Allyn, Inc. - 901076

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: FAM

Device Name: Sigmoidoscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, accessories associated with sigmoidoscope

Definition: to examine and perform procedures within the sigmoid (descending) colon

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: instrument guided through rectum into the large intestine

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: sigmoid (descending) colon

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Identifiers

Device Id: 00732094144024

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00732094236958

Package Quantity: 4

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 00732094236958

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

Device Id: 00732094236965

Device Type: Unit of Use

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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