F7234/1

GUDID 28033695727446

HTC (high temperature cautery) F7234/1 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: 28033695727446
• NIH Device Record Key: 0ae575c5-c04d-49ab-8748-7c4a6a7abd8a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: F7234/1
• Catalog Number: F7234/1
• Company DUNS: 439770017
• Company Name: FIAB SPA
• 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: 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	18033695727449 [Primary]
GS1	28033695727446 [Package]; Contains: 18033695727449; Package: [36 Units]; In Commercial Distribution

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

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