Primary Device ID | 08404535016413 |
NIH Device Record Key | 5af7e33d-7c6b-4c61-a1b2-d875b53f72bd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Axiom Generator |
Version Model Number | BRAXM-UG |
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 | 08404535016413 [Primary] |
LZV | System, cement removal extraction |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08404535016413]
Ethylene Oxide
[08404535016413]
Ethylene Oxide
[08404535016413]
Ethylene Oxide
[08404535016413]
Ethylene Oxide
[08404535016413]
Ethylene Oxide
[08404535016413]
Ethylene Oxide
[08404535016413]
Ethylene Oxide
[08404535016413]
Ethylene Oxide
[08404535016413]
Ethylene Oxide
[08404535016413]
Ethylene Oxide
[08404535016413]
Ethylene Oxide
[08404535016413]
Ethylene Oxide
[08404535016413]
Ethylene Oxide
[08404535016413]
Ethylene Oxide
[08404535016413]
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 |
08404535015539 - Axiom Blades | 2025-06-09 BRAXM-HS6S |
08404535015560 - Axiom Blades | 2025-06-09 BRAXM-FS6S |
08404535015591 - Axiom Blades | 2025-06-09 BRAXM-HS6M |
08404535015621 - Axiom Blades | 2025-06-09 BRAXM-FS6M |
08404535015652 - Axiom Blades | 2025-06-09 BRAXM-FS8S |
08404535015683 - Axiom Blades | 2025-06-09 BRAXM-HS8S |
08404535015713 - Axiom Blades | 2025-06-09 BRAXM-HS8M |
08404535015744 - Axiom Blades | 2025-06-09 BRAXM-FS8M |