VIDEO GASTROSCOPE

GUDID 04961333232505

VIDEO GASTROSCOPE (REFURBISHED)

PENTAX OF AMERICA, INC.

Flexible video gastroscope Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable

• Primary Device ID: 04961333232505
• NIH Device Record Key: eb963004-0e01-472d-80ed-235a8e1afb80
• Commercial Distribution Discontinuation: 2017-04-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VIDEO GASTROSCOPE
• Version Model Number: EG-2930Q
• 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	04961333232505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962897

FDA Product Code

• FDS: Gastroscope And Accessories, Flexible/Rigid

Sterilization

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

[04961333232505]

Ethylene Oxide;High-level Disinfectant

[04961333232505]

Ethylene Oxide;High-level Disinfectant

[04961333232505]

Ethylene Oxide;High-level Disinfectant

[04961333232505]

Ethylene Oxide;High-level Disinfectant

[04961333232505]

Ethylene Oxide;High-level Disinfectant

[04961333232505]

Ethylene Oxide;High-level Disinfectant

[04961333232505]

Ethylene Oxide;High-level Disinfectant

[04961333232505]

Ethylene Oxide;High-level Disinfectant

[04961333232505]

Ethylene Oxide;High-level Disinfectant

[04961333232505]

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 [VIDEO GASTROSCOPE]

• 04961333244683: VIDEO GASTROSCOPE - PTAH
• 04961333244676: VIDEO GASTROSCOPE - PTAH
• 04961333244591: VIDEO GASTROSCOPE - PTAH (USED)
• 04961333244584: VIDEO GASTROSCOPE - PTAH (USED)
• 04961333242917: VIDEO GASTROSCOPE
• 04961333240173: VIDEO GASTROSCOPE (USED)
• 04961333240166: VIDEO GASTROSCOPE VERSION-C (USED)
• 04961333240159: VIDEO GASTROSCOPE (USED)
• 04961333232574: VIDEO GASTROSCOPE 3.8C 2.8C 12.8T FWJ (REFURBISHED)
• 04961333232543: VIDEO GASTROSCOPE 3.8C 11.6T 1050L FWJ (REFURBISHED)
• 04961333232536: VIDEO GASTROSCOPE - I10 STANDARD (REFURBISHED)
• 04961333232529: VIDEO GASTROSCOPE 2.8C 9.8T 1050L (REFURBISHED)
• 04961333232512: HD VIDEO GASTROSCOPE 2.8C 9.8T 1050L (REFURBISHED)
• 04961333232505: VIDEO GASTROSCOPE (REFURBISHED)
• 04961333232499: VIDEO GASTROSCOPE (REFURBISHED)
• 04961333232482: VIDEO GASTROSCOPE - I10 SLIM (REFURBISHED)
• 04961333232475: VIDEO GASTROSCOPE 2.8C 9.0T 1050L (REFURBISHED)
• 04961333232468: HD VIDEO GASTROSCOPE 2.8C 9.0T 1050L (REFURBISHED)
• 04961333232451: VIDEO GASTROSCOPE 2.4C 8.0T 1050L (REFURBISHED)
• 04961333232444: VIDEO GASTROSCOPE 2.0C 5.4T 1050L (REFURBISHED)