Artemis

GUDID 00814548017860

Artemis 2.1 mm

PENUMBRA, INC.

Surgical irrigation/aspiration system

• Primary Device ID: 00814548017860
• NIH Device Record Key: 2bbc1ad9-f2ad-4e85-8e6c-0ddf84c07315
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Artemis
• Version Model Number: AP21-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: 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	00814548017860 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171332

FDA Product Code

• GWG: Endoscope, Neurological

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: 2017-10-17

On-Brand Devices [Artemis]

• 00814548017877: Artemis 2.8 mm
• 00814548017860: Artemis 2.1 mm
• 00814548017846: Artemis 1.5 mm