ENDOCAPSULE RECORDER

ENDOCAPSULE RECORDER - RE-10

Device Description

An electrically-powered, portable component of a video capsule endoscopy system designed to be worn by a patient to continuously display and record photographic image data from an ingested video capsule (not included). It typically incorporates a display and controls and may include connection cables. 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: NEZ

Device Name: System, Imaging, Gastrointestinal, Wireless, Capsule

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 876.1300

Third Party Flag: N

Medical Specialty: GU

Device Identifiers

Device Id: 04953170328244

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