Disposable Focused Irrigating Bipolar Forceps, 8", 1.5mm Straight Tips

GUDID 00817489024003

Box of 5, Disposable Focused Irrigating Bipolar Forceps, 8", 1.5mm Straight Tips

KATALYST SURGICAL LLC

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: 00817489024003
• NIH Device Record Key: fe7a33e1-3e5a-4f21-ad5e-d31169d7383b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Focused Irrigating Bipolar Forceps, 8", 1.5mm Straight Tips
• Version Model Number: DNIF8-15S
• Company DUNS: 007883297
• Company Name: KATALYST SURGICAL LLC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817489024003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123172

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

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