DEFINA

GUDID 04961333249176

PENTAX Medical Video Processor EPK-3000

HOYA CORPORATION

Endoscopic video image processing unit

• Primary Device ID: 04961333249176
• NIH Device Record Key: ee035f2d-ae3e-4de1-9740-f6d3e8a8af21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEFINA
• Version Model Number: EPK-3000
• 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	04961333249176 [Direct Marking]
GS1	04961333249183 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172156

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: 2023-11-08
• Device Publish Date: 2023-10-31

On-Brand Devices [DEFINA]

• 04961333244874: Made in Thailand
• 04961333249176: PENTAX Medical Video Processor EPK-3000