ENDOPRO REVIEW WORKSTATION NA

GUDID 04961333248001

ENDOPRO REVIEW WORKSTATION

PENTAX OF AMERICA, INC.

Medical image management system

• Primary Device ID: 04961333248001
• NIH Device Record Key: ee899b81-ed52-43e3-80ab-787c28aa808f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOPRO REVIEW WORKSTATION
• Version Model Number: KBM68344
• Catalog Number: NA
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	04961333248001 [Primary]

FDA Product Code

• OUG: Medical Device Data System

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: 2020-04-03
• Device Publish Date: 2020-03-26

Devices Manufactured by PENTAX OF AMERICA, INC.

• 04961333255313 - C2 CryoBalloon: 2024-09-20
• 04961333255320 - C2 CryoBalloon: 2024-09-20
• 04961333254309 - MULTI-SPEECH: 2023-09-04 Multi-Speech Microphone, Condensor
• 04961333248117 - Pentax of America: 2022-11-14 Capture Module
• 04961333248445 - C2 CryoBalloon Nitroclip: 2020-08-17 NitroClip
• 00854924006408 - C2 CryoBalloon EndoGrip: 2020-08-06 EndoGrip
• 04961333248001 - ENDOPRO REVIEW WORKSTATION: 2020-04-03ENDOPRO REVIEW WORKSTATION
• 04961333248001 - ENDOPRO REVIEW WORKSTATION: 2020-04-03 ENDOPRO REVIEW WORKSTATION
• 04961333248018 - ENDOPRO NETWORK CAPTURE WORKSTATION: 2020-04-03 ENDOPRO CAPTURE WORKSTATION, NETWORK