SureProbe

GUDID 00850013050086

SureProbe ENT, Larynx, 240mm Malleable Dissecting Tip Assembly

Clinicon Corporation

General/multiple surgical laser system beam guide, single-use

• Primary Device ID: 00850013050086
• NIH Device Record Key: f43ee43f-681a-47f7-afc7-652834ce0f32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureProbe
• Version Model Number: 4149
• Company DUNS: 785275777
• Company Name: Clinicon Corporation
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013050086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014048

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2021-05-13
• Device Publish Date: 2021-05-05

On-Brand Devices [SureProbe]

• 00850013050093: SureProbe ENT, Oto, 70mm Single Curve Assembly
• 00850013050086: SureProbe ENT, Larynx, 240mm Malleable Dissecting Tip Assembly
• 00850013050079: SureProbe ENT, Pedriatric, Larynx, 140mm Malleable Dissecting Tip Assembly
• 00850013050062: SureProbe ENT, 80mm, Oral, Single Curved Dissecting Tip Assembly
• 00850013050055: SureProbe ENT, 80mm, Oral, Straight Dissecting Tip Assembly
• 00850013050048: SureProbe, ENT, 50mm, Nasal, Single Curved Dissecting Tip Assembly
• 00850013050031: SureProbe, ENT, 50mm, Nasal Straight Dissecting Tip Assembly
• 00850013050024: SureProbe, Neuro, 80mm Straight Dissecting Tip Assembly Copy
• 00850013050017: SureProbe, Neuro, 50mm Straight Dissecting Tip Assembly
• 00850013050000: SureProbe, Neuro, 40mm Straight Dissecting Tip Assembly