DEFINA

GUDID 04961333225262

DEFINA HD VIDEO PROCESSOR (US NEW)

PENTAX OF AMERICA, INC.

Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit 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)