IMAGINA

GUDID 04961333248681

Made in Malaysia

HOYA CORPORATION

Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable

• Primary Device ID: 04961333248681
• NIH Device Record Key: bbc14f8c-1c80-4fa9-852a-9a09b1ec6548
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMAGINA
• Version Model Number: EC34-i10cL
• Company DUNS: 691519705
• Company Name: HOYA CORPORATION
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333248681 [Direct Marking]
GS1	04961333248711 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190805

FDA Product Code

• FDF: Colonoscope and accessories, flexible/rigid

Sterilization

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

[04961333248681]

High-level Disinfectant;Liquid Chemical

[04961333248681]

High-level Disinfectant;Liquid Chemical

[04961333248681]

High-level Disinfectant;Liquid Chemical

[04961333248681]

High-level Disinfectant;Liquid Chemical

[04961333248681]

High-level Disinfectant;Liquid Chemical

[04961333248681]

High-level Disinfectant;Liquid Chemical

[04961333248681]

High-level Disinfectant;Liquid Chemical

[04961333248681]

High-level Disinfectant;Liquid Chemical

[04961333248681]

High-level Disinfectant;Liquid Chemical

[04961333248681]

High-level Disinfectant;Liquid Chemical

[04961333248681]

High-level Disinfectant;Liquid Chemical

[04961333248681]

High-level Disinfectant;Liquid Chemical

[04961333248681]

High-level Disinfectant;Liquid Chemical

[04961333248681]

High-level Disinfectant;Liquid Chemical

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-22
• Device Publish Date: 2020-12-14

On-Brand Devices [IMAGINA]

• 04961333237869: EC38-i10cL
• 04961333237654: EC34-i10cL
• 04961333237586: EG29-i10c
• 04961333233670: EPK-i5500c
• 04961333248681: Made in Malaysia
• 04961333248513: Made in Malaysia
• 04961333248452: Made in Malaysia