Axiom Kit

GUDID 08404535016567

BRAXM-UGK

Peter Brasseler Holdings, LLC

Hard/soft-tissue ultrasonic surgical system

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08404535016567 [Primary]

FDA Product Code

• LZV: System, cement removal extraction

Sterilization

• 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

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

• 08404535021769 - BrioPrep Sterile Diamonds: 2026-03-06 BRIO8859.31.014 (F) NEEDLE 25P
• 08404535021790 - BrioPrep Sterile Diamonds: 2026-03-06 BRIO6909.31.040 (C) WHEEL 25P
• 08404535021820 - BrioPrep Sterile Diamonds: 2026-03-06 BRIO8379.31.025 (F) FTBALL 25P
• 08404535021851 - BrioPrep Sterile Diamonds: 2026-03-06 BRIO830L.31.012 (M) PEAR 25P
• 08404535021882 - BrioPrep Sterile Diamonds: 2026-03-06 BRIO368EF.31.023 (EF) FTBLL 25P
• 08404535021912 - BrioPrep Sterile Diamonds: 2026-03-06 BRIO6837.31.012 (C) FLT CYLN 25P
• 08404535021943 - BrioPrep Sterile Diamonds: 2026-03-06 BRIO859EF.31.014 (EF) NDLE 25P
• 08404535021974 - BrioPrep Sterile Diamonds: 2026-03-06 BRIO6859.31.014 (C) NEEDLE 25P