Fomon Rasp

GUDID 00192896113053

Fomon Rasp Double Ended Angled Single Sided Tungsten Carbide Inserts #5/6

SONTEC INSTRUMENTS, INC.

Nasal file/rasp

• Primary Device ID: 00192896113053
• NIH Device Record Key: 0c342eb4-c160-4131-8623-81af466749fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fomon Rasp
• Version Model Number: 345-285A
• Company DUNS: 040729840
• Company Name: SONTEC INSTRUMENTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 8.5 Inch
• Length: 8.5 Inch
• Length: 8.5 Inch
• Length: 8.5 Inch
• Length: 8.5 Inch
• Length: 8.5 Inch
• Length: 8.5 Inch
• Length: 8.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896113053 [Primary]

FDA Product Code

• KBA: RASP, NASAL

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00192896113053]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896113053]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896113053]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896113053]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896113053]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896113053]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896113053]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896113053]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-24
• Device Publish Date: 2022-06-16

On-Brand Devices [Fomon Rasp]

• 00192896078383: FOMON RASP SINGLE ENDED DELICATE TIP
• 00192896078376: FOMON RASP DOUBLE ENDED TUNGSTEN CARBIDE SERRATED TIP #7
• 00192896078369: FOMON RASP DOUBLE ENDED TUNGSTEN CARBIDE SERRATED TIP #3
• 00192896078352: FOMON RASP DOUBLE ENDED TUNGSTEN CARBIDE SERRATED TIP #10
• 00192896078345: FOMON RASP DOUBLE ENDED SINGLE SIDED TUNGSTEN CARBIDE INSERT
• 00192896108554: Fomon Rasp Single-End Tungsten Carbide Serrated Lamb Handle Size #1
• 00192896113077: Fomon Rasp Double Ended Angled Single Sided Tungsten Carbide Inserts #9/10
• 00192896113060: Fomon Rasp Double Ended Angled Single Sided Tungsten Carbide Inserts #7/8
• 00192896113053: Fomon Rasp Double Ended Angled Single Sided Tungsten Carbide Inserts #5/6
• 00192896113046: Fomon Rasp Double Ended Angled Single Sided Tungsten Carbide Inserts #3/4
• 00192896113039: Fomon Rasp Double Ended Angled Single Sided Tungsten Carbide Inserts #1/2