| Primary Device ID | 00850055649705 |
| NIH Device Record Key | 6dde06a0-23b8-46b8-9102-39b8cc410339 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTREPED Extraction Kit |
| Version Model Number | 01-00006 |
| Catalog Number | 01-00006 |
| Company DUNS | 119185571 |
| Company Name | Auxano Medical LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850055649705 [Primary] |
| HWK | Trephine |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850055649705]
Moist Heat or Steam Sterilization
[00850055649705]
Moist Heat or Steam Sterilization
[00850055649705]
Moist Heat or Steam Sterilization
[00850055649705]
Moist Heat or Steam Sterilization
[00850055649705]
Moist Heat or Steam Sterilization
[00850055649705]
Moist Heat or Steam Sterilization
[00850055649705]
Moist Heat or Steam Sterilization
[00850055649705]
Moist Heat or Steam Sterilization
[00850055649705]
Moist Heat or Steam Sterilization
[00850055649705]
Moist Heat or Steam Sterilization
[00850055649705]
Moist Heat or Steam Sterilization
[00850055649705]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-20 |
| Device Publish Date | 2025-01-10 |
| 00810199190006 - ARKEO, Wedge Fixation System | 2025-12-02 ARKEO Cotton Wedge Trial, 16x11x6.5 |
| 00810199190013 - ARKEO, Wedge Fixation System | 2025-12-02 ARKEO Cotton Wedge Trial, 20x14x4.5 |
| 00810199190020 - ARKEO, Wedge Fixation System | 2025-12-02 ARKEO Cotton Wedge Trial, 20x14x5.5 |
| 00810199190037 - ARKEO, Wedge Fixation System | 2025-12-02 ARKEO Cotton Wedge Trial, 20x14x6.5 |
| 00810199190044 - ARKEO, Wedge Fixation System | 2025-12-02 ARKEO Wedge Inserter Handle |
| 00810199190051 - ARKEO, Wedge Fixation System | 2025-12-02 ARKEO Wedge Impactor |
| 00810199190068 - ARKEO, Wedge Fixation System | 2025-12-02 ARKEO Hintermann Distractor |
| 00810199190075 - ARKEO, Wedge Fixation System | 2025-12-02 ARKEO Mallet |