| Primary Device ID | 08903993311455 |
| NIH Device Record Key | a66a7d07-dbd3-4aa2-9cd2-07d7ffb8b31e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Auxein Brand Vertaux 5.5 mm Pedicle Screw System |
| Version Model Number | SP-335 |
| Company DUNS | 872194615 |
| Company Name | Auxein Medical Private Limited |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08903993311455 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08903993311455]
Moist Heat or Steam Sterilization
[08903993311455]
Moist Heat or Steam Sterilization
[08903993311455]
Moist Heat or Steam Sterilization
[08903993311455]
Moist Heat or Steam Sterilization
[08903993311455]
Moist Heat or Steam Sterilization
[08903993311455]
Moist Heat or Steam Sterilization
[08903993311455]
Moist Heat or Steam Sterilization
[08903993311455]
Moist Heat or Steam Sterilization
[08903993311455]
Moist Heat or Steam Sterilization
[08903993311455]
Moist Heat or Steam Sterilization
[08903993311455]
Moist Heat or Steam Sterilization
[08903993311455]
Moist Heat or Steam Sterilization
[08903993311455]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-19 |
| Device Publish Date | 2021-07-09 |
| 08903993401521 | VERTAUX - Polyaxial Pedicle Screw with Cap, Ø5.0mm x Length 25mm, Titanium |
| 08903993401439 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø7.0mm x Length 25mm, Titanium |
| 08903993401422 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.5mm x Length 25mm, Titanium |
| 08903993401415 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.0mm x Length 25mm, Titanium |
| 08903993401408 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.5mm x Length 25mm, Titanium |
| 08903993401392 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.0mm x Length 25mm, Titanium |
| 08903993401385 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø4.5mm x Length 25mm, Titanium |
| 08903993394427 | VERTAUX - Polyaxial Pedicle Screw with Cap, Ø5.0mm x Length 30mm, Titanium |
| 08903993394410 | VERTAUX - Polyaxial Pedicle Screw with Cap, Ø4.5mm x Length 45mm, Titanium |
| 08903993391518 | VERTAUX - Polyaxial Pedicle Screw with Cap, Ø4.5mm x Length 30mm, Titanium |
| 08903993389454 | VERTAUX - Polyaxial Pedicle Screw with Cap, Ø5.0mm x Length 55mm, Titanium |
| 08903993389447 | VERTAUX - Polyaxial Pedicle Screw with Cap, Ø5.0mm x Length 50mm, Titanium |
| 08903993389430 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø7.0mm x Length 30mm, Titanium |
| 08903993389423 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.5mm x Length 30mm, Titanium |
| 08903993389416 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.0mm x Length 30mm, Titanium |
| 08903993389409 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.5mm x Length 55mm, Titanium |
| 08903993389393 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.5mm x Length 30mm, Titanium |
| 08903993389386 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.0mm x Length 55mm, Titanium |
| 08903993389379 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.0mm x Length 50mm, Titanium |
| 08903993389362 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.0mm x Length 30mm, Titanium |
| 08903993389355 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø4.5mm x Length 50mm, Titanium |
| 08903993389348 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø4.5mm x Length 45mm, Titanium |
| 08903993389331 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø4.5mm x Length 30mm, Titanium |
| 08903993389294 | VERTAUX - Polyaxial Pedicle Screw with Cap, Ø4.5mm x Length 50mm, Titanium |
| 08903993355817 | VERTAUX - Polyaxial Pedicle Screw with Cap, Ø4.5mm x Length 25mm, Titanium |
| 08903993310694 | VERTAUX - Polyaxial Pedicle Screw with Cap, Ø5.0mm x Length 45mm, Titanium |
| 08903993310687 | VERTAUX - Polyaxial Pedicle Screw with Cap, Ø5.0mm x Length 40mm, Titanium |
| 08903993310670 | VERTAUX - Polyaxial Pedicle Screw with Cap, Ø5.0mm x Length 35mm, Titanium |
| 08903993310663 | VERTAUX - Polyaxial Pedicle Screw with Cap, Ø4.5mm x Length 40mm, Titanium |
| 08903993310656 | VERTAUX - Polyaxial Pedicle Screw with Cap, Ø4.5mm x Length 35mm, Titanium |
| 08903993310403 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø7.0mm x Length 55mm, Titanium |
| 08903993310397 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø7.0mm x Length 50mm, Titanium |
| 08903993310380 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø7.0mm x Length 45mm, Titanium |
| 08903993310373 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø7.0mm x Length 40mm, Titanium |
| 08903993310359 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.5mm x Length 55mm, Titanium |
| 08903993310342 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.5mm x Length 50mm, Titanium |
| 08903993310335 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.5mm x Length 45mm, Titanium |
| 08903993310328 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.5mm x Length 40mm, Titanium |
| 08903993310311 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.5mm x Length 35mm, Titanium |
| 08903993310304 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.0mm x Length 55mm, Titanium |
| 08903993310298 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.0mm x Length 50mm, Titanium |
| 08903993310281 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.0mm x Length 45mm, Titanium |
| 08903993310274 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.0mm x Length 40mm, Titanium |
| 08903993310267 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.0mm x Length 35mm, Titanium |
| 08903993310250 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.5mm x Length 50mm, Titanium |
| 08903993310243 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.5mm x Length 45mm, Titanium |
| 08903993310236 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.5mm x Length 40mm, Titanium |
| 08903993310229 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.5mm x Length 35mm, Titanium |
| 08903993310212 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.0mm x Length 45mm, Titanium |
| 08903993310205 | VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.0mm x Length 40mm, Titanium |