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

• 08404535021363 - Brasseler USA: 2025-12-25 DCP1F.RA DIACOMP + (F) POINT 5P
• 08404535021394 - Brasseler USA: 2025-12-25 DCP1M.RA DIACOMP + (M) POINT 5P
• 08404535021400 - Brasseler USA: 2025-12-25 DCP3F.RA DIACOMP + (F) CUP 5P
• 08404535021431 - Brasseler USA: 2025-12-25 DCP3M.RA DIACOMP + (M) CUP 5P
• 08404535021462 - Brasseler USA: 2025-12-25 L26MAP (M) CER ADJ/PREPOL 1P
• 08404535021479 - Brasseler USA: 2025-12-25 R22MAP (M) CER ADJ/PREPOL 1P
• 08404535021509 - Brasseler USA: 2025-12-25 R17MAP (M) CER ADJ/PREPOL 1P
• 08404535021530 - Brasseler USA: 2025-12-25 GSZR1.HP GREEN STATE POLISH 6P