F7244

GUDID 28033695727149

HTC (high temperature cautery) F7244 model is a sterile bipolar battery operated disposable device used for the cauterization of tissues and capillary vessels. F7244 model is equipped with fine tip that permits the cauterization of very small vessels and is suitable to be used all the times a quick and precise cauterization is necessary. F7244 reaches a maximum working temperature of 1.200°C (2.200 °F).

FIAB SPA

Electrocautery system generator, battery-powered

• Primary Device ID: 28033695727149
• NIH Device Record Key: 2e989105-4056-4c64-a0d8-a328a84aeb2f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: F7244
• Catalog Number: F7244
• 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	08033695727145 [Unit of Use]
GS1	18033695727142 [Primary]
GS1	28033695727149 [Package]; Contains: 18033695727142; Package: [8 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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