Raptor/Wavy Inner Shaft

GUDID B354C383

Raptor/Wavy Inner Shaft

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: B354C383
• NIH Device Record Key: 412f316b-bfdb-4de0-a3f0-ebd75ecffa0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Raptor/Wavy Inner Shaft
• Version Model Number: C383
• 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	B354C383 [Unit of Use]
HIBCC	B354C3831 [Primary]
HIBCC	B354C3832 [Primary]
HIBCC	B354C3833 [Primary]
HIBCC	B354C3834 [Primary]
HIBCC	B354C3835 [Primary]
HIBCC	B354C3839 [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

[B354C383]

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-24
• Device Publish Date: 2023-07-14

On-Brand Devices [Raptor/Wavy Inner Shaft]

• B354C383: Raptor/Wavy Inner Shaft
• B354C3830: Raptor/Wavy Inner Shaft
• B3543830: Raptor/Wavy Inner Shaft