Lantern Delivery Catheter

GUDID 00814548016627

PXSLIMLAN115T45

PENUMBRA, INC.

Vascular microcatheter

• Primary Device ID: 00814548016627
• NIH Device Record Key: 9d5b869d-e376-4c74-af62-c4e5815f888c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lantern Delivery Catheter
• Version Model Number: PXSLIMLAN115T45
• 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	00814548016627 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2016-07-30

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