| Primary Device ID | 00192896078383 |
| NIH Device Record Key | 6fcdbde7-6e48-4d93-a09b-9cc0aee86d5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FOMON RASP |
| Version Model Number | 345-296 |
| Catalog Number | 345-296 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com |
| Length | 7 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896078383 [Primary] |
| GAC | RASP, SURGICAL, GENERAL & PLASTIC SURGERY |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896078383]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-12-07 |
| Device Publish Date | 2018-09-20 |
| 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 |