REAL Immersive System

GUDID 00815948021037

REAL Immersive System

PENUMBRA, INC.

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• Primary Device ID: 00815948021037
• NIH Device Record Key: aeac7402-f0e0-4b06-ade2-27c4d8eaa3f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REAL Immersive System
• Version Model Number: REAL1
• Company DUNS: 191077671
• Company Name: PENUMBRA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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	00815948021037 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-06-08
• Device Publish Date: 2020-06-17

On-Brand Devices [REAL Immersive System]

• 00815948021037: REAL Immersive System
• 00815948024212: REAL Immersive System, Edu Use
• 00815948024205: REAL Immersive System, Eval Use
• 00815948024229: REAL i-Series
• 00815948024250: REAL y-Series, Edu Use
• 00815948024243: REAL y-Series, Eval Use
• 00815948024236: REAL y-Series