PALMAZ GENESIS Transhepatic Biliary Stent on SLALO PG3980BSX

GUDID 20705032040140

CORDIS CORPORATION

Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent

• Primary Device ID: 20705032040140
• NIH Device Record Key: 005887db-dfc9-4224-bbb6-9f0416cfbb98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALMAZ GENESIS Transhepatic Biliary Stent on SLALO
• Version Model Number: PG3980BSX
• Catalog Number: PG3980BSX
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705032040140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021345

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: 2015-08-28

On-Brand Devices [PALMAZ GENESIS Transhepatic Biliary Stent on SLALO]

• 20705032040140: PG3980BSX
• 20705032040133: PG3980BSS
• 20705032040065: PG3970BSX
• 20705032040058: PG3970BSS
• 20705032039984: PG3960BSX
• 20705032039977: PG3960BSS
• 20705032039908: PG3950BSX
• 20705032039892: PG3950BSS
• 20705032039748: PG2980BSX
• 20705032039731: PG2980BSS
• 20705032039663: PG2970BSX
• 20705032039656: PG2970BSS
• 20705032039588: PG2960BSX
• 20705032039571: PG2960BSS
• 20705032039502: PG2950BSX
• 20705032039496: PG2950BSS
• 20705032039298: PG2480BSX
• 20705032039281: PG2480BSS
• 20705032039199: PG2470BSX
• 20705032038758: PG2430BSX
• 20705032038741: PG2430BSS
• 20705032038611: PG1880BSX
• 20705032038604: PG1880BSS
• 20705032038352: PG1860BSX
• 20705032037959: PG1830BSX
• 20705032037942: PG1830BSS
• 20705032037898: PG1580BSX
• 20705032037881: PG1580BSS
• 20705032037621: PG1560BSS
• 20705032037461: PG1550BSS
• 20705032037232: PG1530BSX
• 20705032037225: PG1530BSS
• 20705032037171: PG1280BSX
• 20705032037164: PG1280BSS
• 20705032036792: PG1250BSX
• 20705032036570: PG1230BSX
• 20705032036563: PG1230BSS