JET 5MAXJETD

GUDID 00814548019734

5MAXJETD-A

PENUMBRA, INC.

Thrombectomy suction catheter

• Primary Device ID: 00814548019734
• NIH Device Record Key: 634c6b6e-80e2-48c5-baf5-5d76571006ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JET
• Version Model Number: 5MAXJETD-A
• Catalog Number: 5MAXJETD
• 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: false
• 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	00814548019734 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113163

FDA Product Code

• NRY: CATHETER, THROMBUS RETRIEVER

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: 2018-09-24
• Device Publish Date: 2018-08-23

On-Brand Devices [JET]

• 00814548019802: 5MAXJETDKIT
• 00814548019796: 5MAXJETD
• 00814548019741: 5MAXJETDKIT-A
• 00814548019734: 5MAXJETD-A