Isto Disposable Funnel System Shooter 6mm Cannula, Pusher 5.5mm IFLX-DFS-6mm

GUDID B90823991238

Isto Disposable Funnel System Shooter 6mm Cannula, Pusher 5.5mm

Mainstream Medical Devices, LLC

Intraoperative orthopaedic bone pin/screw, single-use

• Primary Device ID: B90823991238
• NIH Device Record Key: 73d0e074-0c09-42eb-ab1f-484ab012ffed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isto Disposable Funnel System Shooter 6mm Cannula, Pusher 5.5mm
• Version Model Number: 239-91-238
• Catalog Number: IFLX-DFS-6mm
• Company DUNS: 071513432
• Company Name: Mainstream Medical Devices, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• 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
HIBCC	B90823991238 [Primary]

FDA Product Code

• GEA: Cannula, Surgical, General & Plastic Surgery

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: 2023-07-28
• Device Publish Date: 2023-07-20

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