| Primary Device ID | 00192896117488 | 
| NIH Device Record Key | 4962c465-b5a7-4e11-9a49-480794158f91 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Grooved Director | 
| Version Model Number | 197-692 | 
| Catalog Number | 197-692 | 
| 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 | 
| Length | 5.5 Inch | 
| Length | 5.5 Inch | 
| Length | 5.5 Inch | 
| Length | 5.5 Inch | 
| Length | 5.5 Inch | 
| Length | 5.5 Inch | 
| Length | 5.5 Inch | 
| Length | 5.5 Inch | 
| Length | 5.5 Inch | 
| Length | 5.5 Inch | 
| Length | 5.5 Inch | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00192896117488 [Primary] | 
| FGM | PROBE AND DIRECTOR, GASTRO-UROLOGY | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00192896117488]
Dry Heat Sterilization
[00192896117488]
Dry Heat Sterilization
[00192896117488]
Dry Heat Sterilization
[00192896117488]
Dry Heat Sterilization
[00192896117488]
Dry Heat Sterilization
[00192896117488]
Dry Heat Sterilization
[00192896117488]
Dry Heat Sterilization
[00192896117488]
Dry Heat Sterilization
[00192896117488]
Dry Heat Sterilization
[00192896117488]
Dry Heat Sterilization
[00192896117488]
Dry Heat Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-05-07 | 
| Device Publish Date | 2024-04-29 | 
| 00192896076709 | GROOVED DIRECTOR TONGUE TIE PROBE TIP STAINLESS STEEL | 
| 00192896076693 | GROOVED DIRECTOR TONGUE TIE PROBE TIP STAINLESS STEEL | 
| 00192896076686 | GROOVED DIRECTOR TONGUE TIE PROBE TIP STAINLESS STEEL | 
| 00192896076679 | GROOVED DIRECTOR TONGUE TIE STAINLESS STEEL | 
| 00192896076662 | GROOVED DIRECTOR TONGUE TIE STAINLESS STEEL | 
| 00192896115217 | Grooved Director With Tongue Tie Stainless Steel | 
| 00192896117488 | Grooved Director With Tongue Tie Stainless Steel |