Reusable Monopolar Handle-Tips 34cm

GUDID B3548000015649

Reusable Monopolar Handle-Tips 34cm

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: B3548000015649
• NIH Device Record Key: 565db49a-4bc6-46c4-a53e-6a9b6b340259
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Monopolar Handle-Tips 34cm
• Version Model Number: 8000015649
• Company DUNS: 047063695
• Company Name: ORANGE SURGICAL INSTRUMENTS, LLC
• Device Count: 99999
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	B3548000015649 [Unit of Use]
HIBCC	B35480000156491 [Primary]
HIBCC	B35480000156492 [Primary]
HIBCC	B35480000156493 [Primary]
HIBCC	B35480000156494 [Primary]
HIBCC	B35480000156495 [Primary]
HIBCC	B35480000156499 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101733

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-17
• Device Publish Date: 2023-07-07

On-Brand Devices [Reusable Monopolar Handle-Tips 34cm]

• B3548000015649: Reusable Monopolar Handle-Tips 34cm
• B35480000156490: Reusable Monopolar Handle-Tips 34cm