MicroBlate Fine 7-NP1-100

GUDID 05060359560490

MicroBlate Fine (NP1) is a single-use, sterile electrosurgical instrument for use with the Creo Medical Electrosurgical system. It enables ablation of potential malignant lesions such as nodules or tumors. MicroBlate Fine, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.

CREO MEDICAL LIMITED

Microwave ablation system probe, non-powered

• Primary Device ID: 05060359560490
• NIH Device Record Key: 72028893-3081-49e9-987d-e84c36a8e8ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroBlate Fine
• Version Model Number: 7-NP1-100
• Catalog Number: 7-NP1-100
• Company DUNS: 733853373
• Company Name: CREO MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com
• Phone: +18662261170
• Email: uscustomerservice@creomedical.com

Device Dimensions

• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter
• Length: 1.9 Meter
• Outer Diameter: 2.4 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 109 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060359560483 [Package]; Package: Shipper 5-Up [5 Units]; In Commercial Distribution
GS1	05060359560490 [Package]; Contains: 05060359560971; Package: Carton [1 Units]; In Commercial Distribution
GS1	05060359560971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221672

FDA Product Code

• NEY: System, Ablation, Microwave And Accessories

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: 2025-05-13
• Device Publish Date: 2025-05-05

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• 05060359560490 - MicroBlate Fine: 2025-05-13MicroBlate Fine (NP1) is a single-use, sterile electrosurgical instrument for use with the Creo Medical Electrosurgical system. It enables ablation of potential malignant lesions such as nodules or tumors. MicroBlate Fine, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.
• 05060359560490 - MicroBlate Fine: 2025-05-13 MicroBlate Fine (NP1) is a single-use, sterile electrosurgical instrument for use with the Creo Medical Electrosurgical system.
• 05060359561077 - Speedboat Notch Long: 2025-04-03 Speedboat Notch is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasis, c
• 05060359561213 - CROMA Electrosurgical Generator: 2025-02-18 The CROMA Electrosurgical Generator is a tabletop, non-network connected, mains powered Electrosurgical Unit (ESU). The CROMA E
• 05060359560919 - Croma Generator: 2024-10-16 A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1)
• 05060359560629 - Reusable Interface Cable, 1.5 m: 2024-09-09 The Reusable Interface Cable is only for connection of compatible Creo Medical Instruments (Surgical Accessories) to the CROMA E
• 05060359560650 - Speedboat Ultraslim (SB1L) Electrosurgical Instrument: 2023-12-14 Speedboat UltraSlim is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasi
• 05060359560599 - Speedboat RS2 8 Fr Instrument: 2023-11-16 A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosu