OPTIVISTA

GUDID 04961333233618

HOYA CORPORATION

Endoscopic video image processing unit

• Primary Device ID: 04961333233618
• NIH Device Record Key: c1d505f0-5dd2-4575-811d-fd920a168d52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIVISTA
• Version Model Number: EPK-i7010
• 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: false
• 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	04961333233595 [Direct Marking]
GS1	04961333233618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150618

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-21
• Device Publish Date: 2018-08-10

Devices Manufactured by HOYA CORPORATION

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• 04961333129430 - PENTAX: 2025-04-14 PENTAX Video Colonoscope EC-3890Li
• 04961333172085 - PENTAX: 2025-04-14 PENTAX Video Colonoscope EC38-i10L
• 04961333129492 - PENTAX: 2025-04-14 VIDEO UPPER G.I.SCOPE EG-2990i
• 04961333211692 - PENTAX: 2025-04-14 PENTAX VIDEO UPPER G.I.SCOPE EG29-i10
• 04961333251070 - PENTAX: 2025-04-14 PENTAX Gas/Water Feeding Valve OF-B194
• 84961333253902 - PENTAX: 2025-04-14 Balloon OE-A51
• 84961333253933 - PENTAX: 2025-04-14 PENTAX Medical Single Use Balloon OE-A60