ULTRASOUND GASTROSCOPE

GUDID 04961333232550

RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C (REFURBISHED)

PENTAX OF AMERICA, INC.

Flexible ultrasound gastroduodenoscope

• Primary Device ID: 04961333232550
• NIH Device Record Key: c2845256-a988-4397-98d4-fe7908efc701
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRASOUND GASTROSCOPE
• Version Model Number: EG-3670URK
• 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	04961333232550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130206

FDA Product Code

• ODG: Endoscopic Ultrasound System, Gastroenterology-Urology

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04961333232550]

Ethylene Oxide;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-06

On-Brand Devices [ULTRASOUND GASTROSCOPE]

• 04961333233953: LINEAR ULTRASOUND VIDEO GASTROSCOPE (REFURBISHED)
• 04961333232567: LINEAR ULTRASOUND VIDEO GASTROSCOPE 3.8C (REFURBISHED)
• 04961333232550: RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C (REFURBISHED)