F7234

GUDID 08033695727183

HTC (high temperature cautery) F7234 model is a sterile bipolar battery operated disposable device for the cauterization of small vessels. The fine tip length 75mm permits the accurate and effective cauterization of very small vessels. Tip reaches a maximum working temperature of 1.200°C (2.200 °F). The cautery is suitable to be used all the times a quick and precise cauterization is necessary even in difficult access sites.

FIAB SPA

Electrocautery system generator, battery-powered

• Primary Device ID: 08033695727183
• NIH Device Record Key: 6eba810b-ed2d-490e-886e-1a304fe57f15
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: F7234
• Catalog Number: F7234
• Company DUNS: 439770017
• Company Name: FIAB SPA
• Device Count: 10
• 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: 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: +390558497943
• Email: quality@fiab.it

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033695727183 [Unit of Use]
GS1	18033695727180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100333

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & 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: 2020-05-22
• Device Publish Date: 2020-05-14

Devices Manufactured by FIAB SPA

• 08033003264676 - NA: 2024-03-27 Reusable ECG patient cables
• 08033695726414 - NA: 2023-10-17 ECG patient cables USA version
• 08058480757985 - NA: 2023-07-28 ECG patient cables USA version
• 38033695726514 - F3001ECG: 2023-02-24 Disposable solid gel tab electrode for ECG
• 18058480753984 - SENSITHERM MULTI: 2022-02-14 ST-PROBE-5 is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm)
• 18058480753991 - SENSITHERM MULTI: 2022-02-14 ST-PROBE-7 is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm
• 08058480754021 - SENSITHERM MULITI: 2022-02-14 ST-MONITOR is a device for monitoring of esophageal temperature on three different points; moreover it allows setting of temper
• 08058480754618 - SENSITHERM MULTI: 2022-02-14 The ST-ADPT-30 adapter cable is an accessory for the SENSITHERM MULTI system that can be inserted in a dedicated socket