| Primary Device ID | 00192896031463 |
| NIH Device Record Key | 8ff95ec1-fe74-4f87-987d-f7c55e0874d8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JPS BONE FILE |
| Version Model Number | 345-217 |
| Catalog Number | 345-217 |
| 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 | |
| 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 | |
| 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 | 8.75 Inch |
| Length | 8.75 Inch |
| Length | 8.75 Inch |
| Length | 8.75 Inch |
| Length | 8.75 Inch |
| Length | 8.75 Inch |
| Length | 8.75 Inch |
| Length | 8.75 Inch |
| Length | 8.75 Inch |
| Length | 8.75 Inch |
| Length | 8.75 Inch |
| Length | 8.75 Inch |
| Length | 8.75 Inch |
| Length | 8.75 Inch |
| Length | 8.75 Inch |
| Length | 8.75 Inch |
| Length | 8.75 Inch |
| Length | 8.75 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896031463 [Primary] |
| EMI | FILE, BONE, SURGICAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896031463]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-15 |
| Device Publish Date | 2018-09-13 |
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| 00192896121645 - Debakey Neonatal Clamp | 2025-06-25 Debakey Neonatal Clamp Double Angled 45 Degrees Jaw/Shank A |
| 00192896121652 - Debakey Scissors | 2025-06-25 Debakey Scissors 45 Degree Angle Power Cut |
| 00192896121362 - Barraquer Iris Spatula | 2025-06-16 Barraquer Iris Spatula Round Smooth Curved Blades |
| 00192896121607 - Micasept Top Dur Needle Holder | 2025-06-16 Micasept Top Dur Needle Holder With Hegar Ratchet Curved 4.5 Millimeter Tip |