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 ID05060359560490
NIH Device Record Key72028893-3081-49e9-987d-e84c36a8e8ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicroBlate Fine
Version Model Number7-NP1-100
Catalog Number7-NP1-100
Company DUNS733853373
Company NameCREO MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com

Device Dimensions

Length1.9 Meter
Outer Diameter2.4 Millimeter
Length1.9 Meter
Outer Diameter2.4 Millimeter
Length1.9 Meter
Outer Diameter2.4 Millimeter
Length1.9 Meter
Outer Diameter2.4 Millimeter
Length1.9 Meter
Outer Diameter2.4 Millimeter
Length1.9 Meter
Outer Diameter2.4 Millimeter
Length1.9 Meter
Outer Diameter2.4 Millimeter
Length1.9 Meter
Outer Diameter2.4 Millimeter
Length1.9 Meter
Outer Diameter2.4 Millimeter
Length1.9 Meter
Outer Diameter2.4 Millimeter
Length1.9 Meter
Outer Diameter2.4 Millimeter
Length1.9 Meter
Outer Diameter2.4 Millimeter
Length1.9 Meter
Outer Diameter2.4 Millimeter
Length1.9 Meter
Outer Diameter2.4 Millimeter
Length1.9 Meter
Outer Diameter2.4 Millimeter
Length1.9 Meter
Outer Diameter2.4 Millimeter
Length1.9 Meter
Outer Diameter2.4 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 109 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 109 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 109 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 109 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 109 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 109 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 109 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 109 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 109 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 109 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 109 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 109 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 109 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 109 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 109 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 109 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 109 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060359560483 [Package]
Package: Shipper 5-Up [5 Units]
In Commercial Distribution
GS105060359560490 [Package]
Contains: 05060359560971
Package: Carton [1 Units]
In Commercial Distribution
GS105060359560971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEYSystem, Ablation, Microwave And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-13
Device Publish Date2025-05-05

Devices Manufactured by CREO MEDICAL LIMITED

05060359560490 - MicroBlate Fine2025-05-13MicroBlate 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 Fine2025-05-13 MicroBlate Fine (NP1) is a single-use, sterile electrosurgical instrument for use with the Creo Medical Electrosurgical system.
05060359561077 - Speedboat Notch Long2025-04-03 Speedboat Notch is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasis, c
05060359561213 - CROMA Electrosurgical Generator2025-02-18 The CROMA Electrosurgical Generator is a tabletop, non-network connected, mains powered Electrosurgical Unit (ESU). The CROMA E
05060359560919 - Croma Generator2024-10-16 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 Instrument2023-12-14 Speedboat UltraSlim is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasi
05060359560599 - Speedboat RS2 8 Fr Instrument2023-11-16 A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosu
05060359560193 - Microblate Flex2021-08-06 The AB1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of sof

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