REAL System Bands

GUDID 00815948022416

REAL System Bands

PENUMBRA, INC.

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• 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.

• 00815948028029 - MIDWAY: 2024-04-10 MIDWAY 43 Delivery Catheter, 115cm, no CE
• 00815948028036 - MIDWAY: 2024-04-10 MIDWAY 62 Delivery Catheter, 125cm, no CE
• 00815948028159 - RED 43: 2024-04-10 Reperfusion Catheter RED 43, 153cm, no CE
• 00815948028166 - RED 43: 2024-04-10 Reperfusion Catheter RED 43 Kit, 153cm, Jon Snow Tubing, no CE
• 00815948028173 - RED 43: 2024-04-10 Reperfusion Catheter RED 43 Kit, 153cm, 110 Tubing, no CE
• 00815948028180 - MIDWAY: 2024-04-10 MIDWAY 43 Delivery Catheter, 125cm, No CE
• 00815948028197 - MIDWAY: 2024-04-10 MIDWAY 62 Delivery Catheter, 115cm, no CE
• 00815948029422 - Indigo System: 2024-03-29 CAT16 XTORQ 100cm, Select 135cm H1 Tip, Lightning Flash Tubing