MIDWAY

GUDID 00815948028197

MIDWAY 62 Delivery Catheter, 115cm, no CE

PENUMBRA, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 00815948028197
• NIH Device Record Key: 9b093ed8-31fc-4104-8e28-f3e6f958cb0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIDWAY
• Version Model Number: 62MWAY115-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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815948028197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233201

FDA Product Code

• QJP: Catheter, Percutaneous, Neurovasculature

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-10
• Device Publish Date: 2024-04-02

On-Brand Devices [MIDWAY]

• 00815948028197: MIDWAY 62 Delivery Catheter, 115cm, no CE
• 00815948028180: MIDWAY 43 Delivery Catheter, 125cm, No CE
• 00815948028036: MIDWAY 62 Delivery Catheter, 125cm, no CE
• 00815948028029: MIDWAY 43 Delivery Catheter, 115cm, no CE