Axiom Generator

GUDID 08404535016413

BRAXM-UG

Peter Brasseler Holdings, LLC

Hard/soft-tissue ultrasonic surgical system

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08404535016413 [Primary]

FDA Product Code

• LZV: System, cement removal extraction

Sterilization

• 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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-09
• Device Publish Date: 2025-05-31

Devices Manufactured by Peter Brasseler Holdings, LLC

• 08404535020892 - Forza+: 2026-01-19 Forza+ Z5 1:5 FG
• 08404535020922 - Forza+: 2026-01-19 Forza+ Z1 1:1 Latch
• 08404535020953 - Forza+: 2026-01-19 Forza+ Z450 1:4.2 FG
• 08404535020984 - Forza+: 2026-01-19 Forza+ Z20 1:1 FG
• 08404535021684 - Forza: 2026-01-19 Forza ELXT E Complete Set
• 08404535021714 - Forza: 2026-01-19 Forza ELXT E-U Control Unit
• 08404535021738 - Forza: 2026-01-19 FORZA EZ ENDO
• 08404535021363 - Brasseler USA: 2025-12-25 DCP1F.RA DIACOMP + (F) POINT 5P