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

Devices Manufactured by Peter Brasseler Holdings, LLC

08404535015539 - Axiom Blades2025-06-09 BRAXM-HS6S
08404535015560 - Axiom Blades2025-06-09 BRAXM-FS6S
08404535015591 - Axiom Blades2025-06-09 BRAXM-HS6M
08404535015621 - Axiom Blades2025-06-09 BRAXM-FS6M
08404535015652 - Axiom Blades2025-06-09 BRAXM-FS8S
08404535015683 - Axiom Blades2025-06-09 BRAXM-HS8S
08404535015713 - Axiom Blades2025-06-09 BRAXM-HS8M
08404535015744 - Axiom Blades2025-06-09 BRAXM-FS8M

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