| Primary Device ID | 00192896100749 |
| NIH Device Record Key | 554120ad-4409-473b-9acb-b04a72e8c15b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DEBAKEY NEEDLE HOLDER |
| Version Model Number | 2300-399L |
| 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 | |
| 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 | 6 Inch |
| Length | 6 Inch |
| Length | 6 Inch |
| Length | 6 Inch |
| Length | 6 Inch |
| Length | 6 Inch |
| Length | 6 Inch |
| Length | 6 Inch |
| Length | 6 Inch |
| Length | 6 Inch |
| Length | 6 Inch |
| Length | 6 Inch |
| Length | 6 Inch |
| Length | 6 Inch |
| Length | 6 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896100749 [Primary] |
| FHQ | HOLDER, NEEDLE, GASTROENTEROLOGIC |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896100749]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896100749]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896100749]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896100749]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896100749]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896100749]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896100749]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896100749]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896100749]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896100749]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896100749]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896100749]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896100749]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896100749]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[00192896100749]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-03 |
| Device Publish Date | 2020-02-24 |
| 00192896087477 | DEBAKEY NEEDLE HOLDER WITH BOX LOCK MEDIUM TUNGSTEN CARBIDE SERRATED TIP TITANIUM |
| 00192896087460 | DEBAKEY NEEDLE HOLDER WITH BOX LOCK TUNGSTEN CARBIDE DUST TIP TITANIUM |
| 00192896087453 | DEBAKEY NEEDLE HOLDER WITH BOX LOCK TUNGSTEN CARBIDE DUST TIP TITANIUM |
| 00192896069336 | DEBAKEY NEEDLE HOLDER DOUBLE ACTION STRAIGHT TUNGSTEN CARBIDE DUST TIP TITANIUM |
| 00192896068773 | DEBAKEY NEEDLE HOLDER WITH BOX LOCK MEDIUM TUNGSTEN CARBIDE SERRATED TIP TITANIUM |
| 00192896068766 | DEBAKEY NEEDLE HOLDER WITH BOX LOCK MEDIUM TUNGSTEN CARBIDE SERRATED TIP TITANIUM |
| 00192896062580 | DEBAKEY NEEDLE HOLDER WITH BOX LOCK TUNGSTEN CARBIDE SERRATED TIP RING HANDLE |
| 00192896062573 | DEBAKEY NEEDLE HOLDER WITH BOX LOCK TUNGSTEN CARBIDE SERRATED TIP RING HANDLE |
| 00192896062566 | DEBAKEY NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED LIGHT WEIGHT |
| 00192896062559 | DEBAKEY NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED LIGHT WEIGHT |
| 00192896062542 | DEBAKEY NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED LIGHT WEIGHT |
| 00192896062535 | DEBAKEY NEEDLE HOLDER DELICATE STREAMLINED TUNGSTEN CARBIDE SERRATED TIP |
| 00192896062528 | DEBAKEY NEEDLE HOLDER DELICATE STREAMLINED TUNGSTEN CARBIDE SERRATED TIP |
| 00192896062511 | DEBAKEY NEEDLE HOLDER DELICATE STREAMLINED TUNGSTEN CARBIDE SERRATED TIP |
| 00192896062504 | DEBAKEY NEEDLE HOLDER DELICATE STREAMLINED TUNGSTEN CARBIDE SERRATED TIP |
| 00192896062498 | DEBAKEY NEEDLE HOLDER DELICATE STREAMLINED TUNGSTEN CARBIDE SERRATED TIP |
| 00192896062481 | DEBAKEY NEEDLE HOLDER DELICATE STREAMLINED TUNGSTEN CARBIDE SERRATED TIP |
| 00192896021983 | DEBAKEY NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP OFFSET RINGS |
| 00192896021976 | DEBAKEY NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP OFFSET RINGS |
| 00192896021969 | DEBAKEY NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP OFFSET RINGS |
| 00192896021952 | DEBAKEY NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP OFFSET RINGS |
| 00192896099111 | DEBAKEY NEEDLE HOLDER |
| 00192896100749 | DEBAKEY NEEDLE HOLDER RING HANDLE TUNGSTEN CARBIDE SERRATED DELICATE STREAMLINED LEFT HANDED |
| 00192896094185 | DEBAKEY NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP RING HANDLE |
| 00192896110038 | DeBakey Needle Holder Ring Handle Tungsten Carbide Smooth Quantum |