REAL System Bands

GUDID 00815948022416

REAL System Bands

PENUMBRA, INC.

Virtual-display rehabilitation system, non-supportive, clinical

• Primary Device ID: 00815948022416
• NIH Device Record Key: 697a1ab4-eec8-4d7f-a51f-ee7599ef8cd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REAL System Bands
• Version Model Number: BND-A
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	00815948022416 [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

Devices Manufactured by PENUMBRA, INC.

• 00810169721896 - Swift Coil System: 2025-05-22 Swift Complex CL, 1mm x 2cm
• 00810169721902 - Swift Coil System: 2025-05-22 Swift Complex CL, 1mm x 3cm
• 00810169721919 - Swift Coil System: 2025-05-22 Swift Complex CL, 1mm x 5cm
• 00810169721926 - Swift Coil System: 2025-05-22 Swift Complex CL, 2mm x 2cm
• 00810169721933 - Swift Coil System: 2025-05-22 Swift Complex CL, 2mm x 4cm
• 00810169721940 - Swift Coil System: 2025-05-22 Swift Complex CL, 2mm x 10cm
• 00810169721957 - Swift Coil System: 2025-05-22 Swift Complex CL, 3mm x 6cm
• 00810169721964 - Swift Coil System: 2025-05-22 Swift Complex CL, 3mm x 10cm