| Primary Device ID | B487EXINN9115000 |
| NIH Device Record Key | 39dc9101-6f65-4dd4-954b-137483dcb867 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NanoPhix Instrument Kit |
| Version Model Number | EXINN911500 |
| Catalog Number | EXINN911500 |
| Company DUNS | 116722111 |
| Company Name | Exsomed Corporation |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B487EXINN9115000 [Primary] |
| HXI | Passer, Wire, Orthopedic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-09-18 |
| Device Publish Date | 2022-11-01 |
| B487EXINN9215060 - NanoPhix Implant | 2024-02-01 NanoPhix is a stainless steel bone screw. |
| B487EXINN9215070 - NanoPhix Implant | 2024-02-01 NanoPhix is a stainless steel bone screw. |
| B487EXINN9215080 - NanoPhix Implant | 2024-02-01 NanoPhix is a stainless steel bone screw. |
| B487EXINN9215090 - NanoPhix Implant | 2024-02-01 NanoPhix is a stainless steel bone screw. |
| B487EXINN9215100 - NanoPhix Implant | 2024-02-01 NanoPhix is a stainless steel bone screw. |
| B487EXINN9215110 - NanoPhix Implant | 2024-02-01 NanoPhix is a stainless steel bone screw. |
| B487EXINN9215120 - NanoPhix Implant | 2024-02-01 NanoPhix is a stainless steel bone screw. |
| B487EXINN9215130 - NanoPhix Implant | 2024-02-01 NanoPhix is a stainless steel bone screw. |