| Primary Device ID | 00192896113558 |
| NIH Device Record Key | 146005a7-d76d-4344-b32f-104695522e7e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hibbs Gouge |
| Version Model Number | 330-590 |
| 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 |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896113558 [Primary] |
| GDH | GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896113558]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896113558]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896113558]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896113558]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896113558]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896113558]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896113558]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896113558]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896113558]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896113558]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896113558]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-09 |
| Device Publish Date | 2022-08-01 |
| 00192896078048 | HIBBS GOUGE STRAIGHT TIP |
| 00192896113558 | Hibbs Gouge Straight 9.5 Inches X .25 Inches |