Lantern Delivery Catheter

GUDID 00815948023017

PXSLIMLAN160T45

PENUMBRA, INC.

Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter

• Primary Device ID: 00815948023017
• NIH Device Record Key: 736947b3-043c-4433-a27d-7d3f8bf54d85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lantern Delivery Catheter
• Version Model Number: PXSLIMLAN160T45
• Company DUNS: 191077671
• Company Name: PENUMBRA, 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815948023017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152840

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

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: 2022-02-17
• Device Publish Date: 2022-02-09

On-Brand Devices [Lantern Delivery Catheter]

• 00814548016696: PXSLIMLAN150T90
• 00814548016689: PXSLIMLAN150T45
• 00814548016672: PXSLIMLAN150STR
• 00814548016665: PXSLIMLAN135T90
• 00814548016658: PXSLIMLAN135T45
• 00814548016641: PXSLIMLAN135STR
• 00814548016634: PXSLIMLAN115T90
• 00814548016627: PXSLIMLAN115T45
• 00814548016610: PXSLIMLAN115STR
• 00815948023024: PXSLIMLAN160T90
• 00815948023017: PXSLIMLAN160T45
• 00815948023000: PXSLIMLAN160STR