Mano4336W(k Taicang)

GUDID 06972093830151

Mano4336W Wireless Digital Flat Panel Detector K201004 Taicang

iRay Technology Taicang Ltd.

Indirect flat panel x-ray detector

• Primary Device ID: 06972093830151
• NIH Device Record Key: 39b53f05-ac37-413f-a484-1d4a47e64991
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mano4336W(k Taicang)
• Version Model Number: Mano4336W
• Company DUNS: 543860743
• Company Name: iRay Technology Taicang Ltd.
• 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	06972093830151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201004

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: 2020-05-25
• Device Publish Date: 2020-05-15

Devices Manufactured by iRay Technology Taicang Ltd.

• 06972093830168 - iRay(k Taicang): 2021-11-08 Mars1717V-VSI Wireless Digital Flat Panel Detector k201043 Taicang
• 06972093830175 - Mano4343W(k Taicang): 2021-11-08 Mano4343W Wireless Digital Flat Panel Detector k201043 Taicang
• 06972093830120 - iRay(k): 2020-05-25 Mars1717V-VSI Wireless Digital Flat Panel Detector k201043 made in Korea
• 06972093830137 - Mano4343W(k): 2020-05-25 Mnao4343W Wireless Digital Flat Panel Detector k201043 made in Korea
• 06972093830144 - iRay(k Taicang): 2020-05-25 Mars1417V-TSI Wireless Digital Flat Panel Detector k201004 Taicang
• 06972093830151 - Mano4336W(k Taicang): 2020-05-25Mano4336W Wireless Digital Flat Panel Detector K201004 Taicang
• 06972093830151 - Mano4336W(k Taicang): 2020-05-25 Mano4336W Wireless Digital Flat Panel Detector K201004 Taicang
• 06972093830106 - iRay(k): 2020-05-18 Mars1417V-TSI Wireless Digital Flat Panel Detector k201004 made in Korea
• 06972093830113 - Mano4336W(k): 2020-05-18 Mano4336W Wireless Digital Flat Panel Detector K201004 made in Korea