recorder, DR3
Pillcam - FGS-0347
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
- 40.00
- 0.00
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 IdentifiersDevice Id: 07290101362951
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