sensor belt, DR3 C2

sensor belt, DR3 C2
Pillcam - FGS-0443

An electrically-powered, noninvasive component of a video capsule endoscopy system designed to be attached to/worn by a patient to receive the image data signals from an ingested video capsule and transmit them to the system monitor. It typically has the form of a metallic plate(s) or adhesive pad(s) with connection cables. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PGD

Device Name: Colon Capsule Imaging System

Device Class: 2

Physical State: capsule

Definition: visualization of the colon for the detection of polyps

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device is a single-use ingestible capsule designed to acquire video images during natural propulsion through the digestive system. It is specifically designed to visualize the complex anatomy of the colon

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: colon

Regulation Number: 876.1330

Third Party Flag: N

Medical Specialty: GU

Device Id: 07290101363002

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