IMAGINA

GUDID 04961333233670

HOYA CORPORATION

Endoscopic video image processing unit

• Primary Device ID: 04961333233670
• NIH Device Record Key: 19821bab-b258-4671-88b7-ae1d976e90f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMAGINA
• Version Model Number: EPK-i5500c
• 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	04961333232918 [Primary]
GS1	04961333233670 [Direct Marking]

FDA Product Code

• PEA: Endoscope, accessories, image post-processing for color enhancement

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: 2020-07-27
• Device Publish Date: 2020-07-17

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