ACE

GUDID 00814548016528

5MAXACE068L127

PENUMBRA, INC.

Thrombectomy suction catheter

• Primary Device ID: 00814548016528
• NIH Device Record Key: 5802e3bf-a73f-4d00-828d-f423801a2cab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACE
• Version Model Number: 5MAXACE068L127
• 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	00814548016528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142458

FDA Product Code

• NRY: CATHETER, THROMBUS RETRIEVER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-23

On-Brand Devices [ACE]

• 00814548016603: 5MAXACE068KIT
• 00814548016535: 5MAXACE068
• 00814548016528: 5MAXACE068L127
• 00814548016511: 5MAXACE068L125
• 00814548016504: 5MAXACE068L120
• 00814548016498: 5MAXACE068L115
• 00814548016467: 5MAXACE064KIT
• 00814548014005: RC ACE 64, 127cm
• 00814548013992: RC ACE 64, 125cm
• 00814548013985: RC ACE 64, 120cm
• 00814548013978: RC ACE 64, 115cm
• 00814548013961: RC ACE 64, 132cm
• 00815948022850: 5MAXACE068KIT
• 00815948022843: 5MAXACE068