REAL y-Series

GUDID 00815948029477

REAL y-Series 2 Eval

PENUMBRA, INC.

Virtual-display rehabilitation system, non-supportive, clinical

• Primary Device ID: 00815948029477
• NIH Device Record Key: c276678b-ebc2-4b35-bcb5-3535db0eae9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REAL y-Series
• Version Model Number: RLY2EVAL-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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815948029477 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183296

FDA Product Code

• ISD: Exerciser, Measuring

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-24
• Device Publish Date: 2024-04-16

On-Brand Devices [REAL y-Series]

• 00815948029484: REAL y-Series GO
• 00815948029477: REAL y-Series 2 Eval
• 00815948029460: REAL y-Series 2