VIDEO DUODENOSCOPE

GUDID 04961333232956

C.A.P. HD DUODENOSCOPE (US NEW)

PENTAX OF AMERICA, INC.

Flexible video duodenoscope, reusable

• Primary Device ID: 04961333232956
• NIH Device Record Key: dec845dd-2ef2-4eaf-889b-9835bc0422e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIDEO DUODENOSCOPE
• Version Model Number: ED34-I10T-US
• 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	04961333232956 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163614

FDA Product Code

• FDT: Duodenoscope And Accessories, Flexible/Rigid

Sterilization

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

[04961333232956]

Ethylene Oxide;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-23
• Device Publish Date: 2018-03-12

On-Brand Devices [VIDEO DUODENOSCOPE]

• 04961333240142: C.A.P. HD DUODENOSCOPE (US USED)
• 04961333240135: VIDEO DUODENOSCOPE (USED)
• 04961333240128: VIDEO DUODENOSCOPE - I10 STANDARD (INTERNATIONAL USED)
• 04961333232956: C.A.P. HD DUODENOSCOPE (US NEW)
• 04961333232420: ED-3490TK VIDEO DUODENOSCOPE (REFURBISHED)