FIBER PANCREATOSCOPE

GUDID 04961333232727

PERORAL CHOLEDOCHO, FIBER SCOPE, TD2.7,C (REFURBISHED)

PENTAX OF AMERICA, INC.

Flexible fibreoptic choledochoscope

• Primary Device ID: 04961333232727
• NIH Device Record Key: 63c121de-39f2-40e7-9368-01c3c808e3f4
• Commercial Distribution Discontinuation: 2017-04-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: FIBER PANCREATOSCOPE
• Version Model Number: FCP-8P
• 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	04961333232727 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953286

FDA Product Code

• FBN: Choledochoscope And Accessories, Flexible/Rigid

Sterilization

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

[04961333232727]

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 [FIBER PANCREATOSCOPE]

• 04961333240265: FIBEROPTIC CHOLANGIO-PANCREATOSCOPE 1.2C (USED)
• 04961333232727: PERORAL CHOLEDOCHO, FIBER SCOPE, TD2.7,C (REFURBISHED)