| Primary Device ID | 08404535016383 |
| NIH Device Record Key | 805f85bc-0ada-4f10-a620-e5bd6445c148 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Axiom Handle |
| Version Model Number | BRAXM-HM |
| Company DUNS | 082080136 |
| Company Name | Peter Brasseler Holdings, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08404535016383 [Primary] |
| LZV | System, cement removal extraction |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08404535016383]
Ethylene Oxide
[08404535016383]
Ethylene Oxide
[08404535016383]
Ethylene Oxide
[08404535016383]
Ethylene Oxide
[08404535016383]
Ethylene Oxide
[08404535016383]
Ethylene Oxide
[08404535016383]
Ethylene Oxide
[08404535016383]
Ethylene Oxide
[08404535016383]
Ethylene Oxide
[08404535016383]
Ethylene Oxide
[08404535016383]
Ethylene Oxide
[08404535016383]
Ethylene Oxide
[08404535016383]
Ethylene Oxide
[08404535016383]
Ethylene Oxide
[08404535016383]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-09 |
| Device Publish Date | 2025-05-31 |
| 08404535016383 | BRAXM-HM |
| 08404535016352 | BRAXM-HL |