Palmaz XL Unmounted Stent P3110

GUDID 20705032057322

CORDIS CORPORATION

Bare-metal biliary stent

• Primary Device ID: 20705032057322
• NIH Device Record Key: 9a1770f0-208d-46c3-88b2-d038b61967be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Palmaz XL Unmounted Stent
• Version Model Number: P3110
• Catalog Number: P3110
• 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: false
• 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	20705032057322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993091

FDA Product Code

• FGE: CATHETER, BILIARY, DIAGNOSTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-31

On-Brand Devices [Palmaz XL Unmounted Stent]

• 20705032057377: P5010
• 20705032057353: P4010
• 20705032057322: P3110
• 10705032057325: P3110