| Primary Device ID | 00192896113619 |
| NIH Device Record Key | 0bf71d97-7bc1-47ec-9405-2abb30fd6ad4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Smith-Petersen Osteotome |
| Version Model Number | 330-624 |
| 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 | |
| Phone | +1(800)821-7496 |
| info@sontecinstruments.com |
| Length | 8 Inch |
| Device Size Text, specify | 0 |
| Length | 8 Inch |
| Device Size Text, specify | 0 |
| Length | 8 Inch |
| Device Size Text, specify | 0 |
| Length | 8 Inch |
| Device Size Text, specify | 0 |
| Length | 8 Inch |
| Device Size Text, specify | 0 |
| Length | 8 Inch |
| Device Size Text, specify | 0 |
| Length | 8 Inch |
| Device Size Text, specify | 0 |
| Length | 8 Inch |
| Device Size Text, specify | 0 |
| Length | 8 Inch |
| Device Size Text, specify | 0 |
| Length | 8 Inch |
| Device Size Text, specify | 0 |
| Length | 8 Inch |
| Device Size Text, specify | 0 |
| Length | 8 Inch |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896113619 [Primary] |
| HWM | OSTEOTOME |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896113619]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113619]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113619]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113619]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113619]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113619]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113619]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113619]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113619]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113619]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113619]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896113619]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-16 |
| Device Publish Date | 2022-08-08 |
| 00192896090118 | SMITH-PETERSEN OSTEOTOME CURVED TIP |
| 00192896078055 | SMITH-PETERSEN OSTEOTOME CURVED TIP |
| 00192896030008 | SMITH-PETERSEN OSTEOTOME STRAIGHT TIP |
| 00192896029996 | SMITH-PETERSEN OSTEOTOME STRAIGHT TIP |
| 00192896029989 | SMITH-PETERSEN OSTEOTOME STRAIGHT TIP |
| 00192896029972 | SMITH-PETERSEN OSTEOTOME STRAIGHT TIP |
| 00192896029965 | SMITH-PETERSEN OSTEOTOME STRAIGHT TIP |
| 00192896029958 | SMITH-PETERSEN OSTEOTOME STRAIGHT TIP |
| 00192896029941 | SMITH-PETERSEN OSTEOTOME STRAIGHT TIP |
| 00192896113626 | Smith-Petersen Osteotome Curved Tip |
| 00192896113619 | Smith-Petersen Osteotome Curved Tip |
| 00192896115248 | Smith-Petersen Osteotome Curved Tip |