| Primary Device ID | 08404535016567 |
| NIH Device Record Key | 2a07cdf6-be59-4a37-aac0-4df325a99bc6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Axiom Kit |
| Version Model Number | BRAXM-UGK |
| 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 | 08404535016567 [Primary] |
| LZV | System, cement removal extraction |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08404535016567]
Ethylene Oxide
[08404535016567]
Ethylene Oxide
[08404535016567]
Ethylene Oxide
[08404535016567]
Ethylene Oxide
[08404535016567]
Ethylene Oxide
[08404535016567]
Ethylene Oxide
[08404535016567]
Ethylene Oxide
[08404535016567]
Ethylene Oxide
[08404535016567]
Ethylene Oxide
[08404535016567]
Ethylene Oxide
[08404535016567]
Ethylene Oxide
[08404535016567]
Ethylene Oxide
[08404535016567]
Ethylene Oxide
[08404535016567]
Ethylene Oxide
[08404535016567]
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 |
| 08404535019919 - Sterilization Tray | 2025-09-22 BR-9709 |
| 00887919649816 - Brasseler USA | 2025-09-15 K7-2190-50F |
| 08404535019520 - Sterilization Tray | 2025-08-18 BR-9708K |
| 08404535019278 - Axiom Blades | 2025-08-05 BRAXM-FL6LH |
| 08404535019308 - Axiom Blades | 2025-08-05 BRAXM-EXT |
| 08404535015539 - Axiom Blades | 2025-06-09 BRAXM-HS6S |
| 08404535015560 - Axiom Blades | 2025-06-09 BRAXM-FS6S |
| 08404535015591 - Axiom Blades | 2025-06-09 BRAXM-HS6M |