VIDEO GASTROSCOPE

GUDID 04961333232543

VIDEO GASTROSCOPE 3.8C 11.6T 1050L FWJ (REFURBISHED)

PENTAX OF AMERICA, INC.

Flexible video gastroscope

• Primary Device ID: 04961333232543
• NIH Device Record Key: b4e20be5-daf8-4a1a-8c4d-acecfbf2165a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIDEO GASTROSCOPE
• Version Model Number: EG-3490K
• 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	04961333232543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131902

FDA Product Code

• FDS: Gastroscope And Accessories, Flexible/Rigid

Sterilization

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

[04961333232543]

Ethylene Oxide;High-level Disinfectant

[04961333232543]

Ethylene Oxide;High-level Disinfectant

[04961333232543]

Ethylene Oxide;High-level Disinfectant

[04961333232543]

Ethylene Oxide;High-level Disinfectant

[04961333232543]

Ethylene Oxide;High-level Disinfectant

[04961333232543]

Ethylene Oxide;High-level Disinfectant

[04961333232543]

Ethylene Oxide;High-level Disinfectant

[04961333232543]

Ethylene Oxide;High-level Disinfectant

[04961333232543]

Ethylene Oxide;High-level Disinfectant

[04961333232543]

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)