Axiom Kit

GUDID 08404535016567

BRAXM-UGK

Peter Brasseler Holdings, LLC

Hard/soft-tissue ultrasonic surgical system
Primary Device ID08404535016567
NIH Device Record Key2a07cdf6-be59-4a37-aac0-4df325a99bc6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxiom Kit
Version Model NumberBRAXM-UGK
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
GS108404535016567 [Primary]

FDA Product Code

LZVSystem, cement removal extraction

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

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

Devices Manufactured by Peter Brasseler Holdings, LLC

08404535022452 - Axiom Blades2025-12-18 BRAXM-SS6PR SLIT SCRAPER
08404535022483 - Axiom Blades2025-12-18 BRAXM-FS6PR FULL SCRAPER
08404535022506 - Axiom Blades2025-12-18 BRAXM-D3PR DRILL 3X300MM
08404535022568 - Axiom Blades2025-12-18 BRAXM-HS5PR HOE SCRAPER
08404535022599 - Axiom Blades2025-12-18 BRAXM-EXTSXL STEP EXTENDER 190
08404535022629 - Axiom Blades2025-12-18 BRAXM-RS6 RAKE SCRAPER 5.6X190
08404535022650 - Axiom Blades2025-12-18 BRAXM-EXTXL EXTENDER 190
08404535022681 - Axiom Blades2025-12-18 BRAXM-FS6PRXL FULL SCRAPER

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