VIDEO PROCESSOR

GUDID 04961333228928

EPK-1000 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 Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit

• Primary Device ID: 04961333228928
• NIH Device Record Key: feb55aaf-4047-4598-a658-63845ffc0fb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIDEO PROCESSOR
• Version Model Number: EPK-1000-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	04961333228928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934918

FDA Product Code

• FET: Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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: 2018-04-16

On-Brand Devices [VIDEO PROCESSOR]

• 04961333244690: VIDEO PROCESSOR - PTAH (VERSA)
• 04961333244607: VIDEO PROCESSOR - PTAH (VERSA) (USED)
• 04961333240234: VIDEO PROCESSOR (INTERNATIONAL USED)
• 04961333240227: VIDEO PROCESSOR (INTERNATIONAL USED)
• 04961333240210: VIDEO PROCESSOR (BRAZIL USED)
• 04961333240203: VIDEO PROCESSOR (USED)
• 04961333240197: VIDEO PROCESSOR (INTERNATIONAL USED)
• 04961333240180: EPK-1000 VIDEO PROCESSOR (INTERNATIONAL USED)
• 04961333232628: VIDEO PROCESSOR (REFURBISHED)
• 04961333232611: VIDEO PROCESSOR (REFURBISHED)
• 04961333232604: VIDEO PROCESSOR (US USED)
• 04961333232598: VIDEO PROCESSOR (US USED)
• 04961333232581: EPK-1000 VIDEO PROCESSOR (US USED)
• 04961333231942: VIDEO PROCESSOR (US NEW)
• 04961333228928: EPK-1000 VIDEO PROCESSOR (US NEW)