ENTEROSCOPE

GUDID 04961333232925

SMBOWEL ENTEROSCOPE 3.8C 11.6T 2200L FWJ (REFURBISHED)

PENTAX OF AMERICA, INC.

Flexible video enteroscope

• Primary Device ID: 04961333232925
• NIH Device Record Key: 72cd9915-995c-468a-97e2-8a3f592d07e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENTEROSCOPE
• Version Model Number: VSB-3430K
• 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	04961333232925 [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

[04961333232925]

Ethylene Oxide;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2017-04-06

On-Brand Devices [ENTEROSCOPE]

• 04961333240470: VIDEO SMALL BOWEL ENTEROSCOPE (USED)
• 04961333232925: SMBOWEL ENTEROSCOPE 3.8C 11.6T 2200L FWJ (REFURBISHED)