DEFINA

GUDID 04961333225262

DEFINA HD VIDEO PROCESSOR (US NEW)

PENTAX OF AMERICA, INC.

Endoscopic video image processing unit

• Primary Device ID: 04961333225262
• NIH Device Record Key: a1c6acf5-9ca0-47c7-8fc8-31d27aa527a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEFINA
• Version Model Number: EPK-3000-US
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, INC.
• 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	04961333225262 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-21
• Device Publish Date: 2018-04-16

On-Brand Devices [DEFINA]

• 04961333245208: DEFINA HD VIDEO PROCESSOR (US USED)
• 04961333225262: DEFINA HD VIDEO PROCESSOR (US NEW)