PX400 Microcatheter

GUDID 00814548011653

Penumbra Cat 025 STR

PENUMBRA, INC.

Vascular microcatheter

• Primary Device ID: 00814548011653
• NIH Device Record Key: 99b238e0-4895-43c8-946e-33fdac20099e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PX400 Microcatheter
• Version Model Number: PX400STR-A
• 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	00814548011653 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100826

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 [PX400 Microcatheter]

• 00814548011653: Penumbra Cat 025 STR
• 00814548011646: Penumbra Cat 025 J
• 00814548011639: Penumbra Cat 025 90Deg
• 00814548011622: Penumbra Cat 025 45Deg