Palmaz Genesis PG795B

GUDID 20705032057629

CORDIS CORPORATION

Bare-metal biliary stent

• Primary Device ID: 20705032057629
• NIH Device Record Key: 8f726e73-dd1c-4120-9c40-025649f1564c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Palmaz Genesis
• Version Model Number: PG795B
• Catalog Number: PG795B
• 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	20705032057629 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012087
• Premarket Notification: K012090

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 Genesis]

• 20705032057629: PG795B
• 20705032057605: PG595B
• 20705032057582: PG5910B
• 20705032057568: PG395B
• 20705032057544: PG3910B
• 20705032057520: PG295B
• 20705032057506: PG2910B
• 20705032057490: PG2510B
• 20705032057476: PG244B
• 20705032057452: PG1910B
• 20705032057438: PG184B
• 20705032057414: PG154B
• 20705032057391: PG124B
• 20705032057612: STENT GENESIS 59MM PERIPHERAL
• 20705032057575: STENT GENESIS 39MM PERIPHERAL
• 20705032057537: STENT GENESIS 29MM PERIPHERAL
• 20705032057445: STENT GENESIS 18MM PERIPHERAL
• 20705032057407: STENT GENESIS 12MM PERIPHERAL