Axiom Generator

GUDID 08404535016413

BRAXM-UG

Peter Brasseler Holdings, LLC

Hard/soft-tissue ultrasonic surgical system
Primary Device ID08404535016413
NIH Device Record Key5af7e33d-7c6b-4c61-a1b2-d875b53f72bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxiom Generator
Version Model NumberBRAXM-UG
Company DUNS082080136
Company NamePeter Brasseler Holdings, LLC
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108404535016413 [Primary]

FDA Product Code

LZVSystem, cement removal extraction

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-09
Device Publish Date2025-05-31

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08404535005011 - Brasseler USA2025-11-26 DIGITAL POSITIONING SYSTEM
08404535005042 - Brasseler USA2025-11-26 ANTERIOR POSITIONING ARM
08404535005073 - Brasseler USA2025-11-26 ANTERIOR POSITIONING RING
08404535005103 - Brasseler USA2025-11-26 ADHESIVE SENSOR HOLDER
08404535005165 - Brasseler USA2025-11-26 POSTERIOR POSITIONING ARM
08404535005196 - Brasseler USA2025-11-26 POSTERIOR POSITIONING RING
08404535005318 - Brasseler USA2025-11-26 ADHESIVE SENSOR HOLDER

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