PX SLIM Delivery Microcatheter

GUDID 00814548012551

AdvPX400 45Deg 160DualMB

PENUMBRA, INC.

Vascular microcatheter

• Primary Device ID: 00814548012551
• NIH Device Record Key: 0cc6116c-e2bc-4d3d-8e8f-b0ea14543355
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PX SLIM Delivery Microcatheter
• Version Model Number: PXSLIM160045-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	00814548012551 [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 [PX SLIM Delivery Microcatheter]

• 00814548016450: PXSLIM130
• 00814548016443: PXSLIMSTR-B
• 00814548016436: PXSLIMSTR-A
• 00814548016429: PXSLIM090
• 00814548016412: PXSLIM045-B
• 00814548016405: PXSLIM045-A
• 00814548012575: AdvPX400 J 160DualMB
• 00814548012568: AdvPX400 90Deg 160DualMB
• 00814548012551: AdvPX400 45Deg 160DualMB
• 00814548012537: PXSLIM 150Micro, 130Deg
• 00814548012520: PXSLIM 150Micro, 90Deg
• 00814548012513: AdvPX400 45Deg 150DualMB
• 00814548012506: AdvPX400 STR 150DualMB
• 00814548010465: PXSLIM 150Micro, 130Deg
• 00814548010342: PXSLIM 150Micro, 90Deg