Wireless Digital Flat Panel Detector

GUDID 08800061700015

Mars1417V-TSI Wireless Flat Panel Detector with only one package

iRay Korea Limited

Indirect flat panel x-ray detector

• Primary Device ID: 08800061700015
• NIH Device Record Key: 0d2dc364-75e7-47da-b515-b2e8835cdd15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wireless Digital Flat Panel Detector
• Version Model Number: Mars1417V-TSI
• Company DUNS: 695735752
• Company Name: iRay Korea Limited
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800061700015 [Primary]

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-09
• Device Publish Date: 2019-10-01