Axiom Accessories

GUDID 08404535016475

BRAXM-STC

Peter Brasseler Holdings, LLC

Hard/soft-tissue ultrasonic surgical system
Primary Device ID08404535016475
NIH Device Record Key8f746a7c-7d82-4f2c-ab84-c899dba43a2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxiom Accessories
Version Model NumberBRAXM-STC
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
GS108404535016475 [Primary]

FDA Product Code

LZVSystem, cement removal extraction

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08404535016475]

Ethylene Oxide


[08404535016475]

Ethylene Oxide


[08404535016475]

Ethylene Oxide


[08404535016475]

Ethylene Oxide


[08404535016475]

Ethylene Oxide


[08404535016475]

Ethylene Oxide


[08404535016475]

Ethylene Oxide


[08404535016475]

Ethylene Oxide


[08404535016475]

Ethylene Oxide


[08404535016475]

Ethylene Oxide


[08404535016475]

Ethylene Oxide


[08404535016475]

Ethylene Oxide


[08404535016475]

Ethylene Oxide


[08404535016475]

Ethylene Oxide


[08404535016475]

Ethylene Oxide


Device Entry Metadata

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

On-Brand Devices [Axiom Accessories]

08404535016536BRAXM-CL
08404535016505BRAXM-FS
08404535016475BRAXM-STC
08404535016444BRAXM-CWW

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