PALMAZ BLUE PB1250PPS

GUDID 20705032062029

Blue/AviatorPlus 5x12/80P PKG

CORDIS CORPORATION

Bare-metal biliary stent

• Primary Device ID: 20705032062029
• NIH Device Record Key: 734ba1f2-d9ee-4472-8300-11025086a028
• Commercial Distribution Discontinuation: 2024-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PALMAZ BLUE
• Version Model Number: PB1250PPS
• Catalog Number: PB1250PPS
• Company DUNS: 806136177
• Company Name: CORDIS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	10705032062022 [Primary]
GS1	20705032062029 [Package]; Contains: 10705032062022; Package: Box [1 Units]; Discontinued: 2024-07-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040413

FDA Product Code

• FGE: Stents, drains and dilators for the biliary ducts

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-08
• Device Publish Date: 2024-07-31

On-Brand Devices [PALMAZ BLUE]

• 20705032062296: Blue/AviatorPlus 7x24/80P PKG
• 20705032062258: Blue/AviatorPlus 5x24/80P PKG
• 20705032062029: Blue/AviatorPlus 5x12/80P PKG