Axiom Blades

GUDID 08404535015843

BRAXM-C5R

Peter Brasseler Holdings, LLC

Hard/soft-tissue ultrasonic surgical system
Primary Device ID08404535015843
NIH Device Record Key4356d858-336a-45c0-8ce0-179179c23ec3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxiom Blades
Version Model NumberBRAXM-C5R
Company DUNS082080136
Company NamePeter Brasseler Holdings, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108404535015843 [Primary]

FDA Product Code

LZVSystem, cement removal extraction

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[08404535015843]

Ethylene Oxide


[08404535015843]

Ethylene Oxide


[08404535015843]

Ethylene Oxide


[08404535015843]

Ethylene Oxide


[08404535015843]

Ethylene Oxide


[08404535015843]

Ethylene Oxide


[08404535015843]

Ethylene Oxide


[08404535015843]

Ethylene Oxide


[08404535015843]

Ethylene Oxide


[08404535015843]

Ethylene Oxide


[08404535015843]

Ethylene Oxide


[08404535015843]

Ethylene Oxide


[08404535015843]

Ethylene Oxide


[08404535015843]

Ethylene Oxide


[08404535015843]

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 Blades]

08404535016628BRAXM-FP10M
08404535016321BRAXM-EXTS
08404535016291BRAXM-EXTM
08404535016260BRAXM-EXTL
08404535016239BRAXM-PFC5R
08404535016208BRAXM-PFC5FL
08404535016178BRAXM-PFC5FS
08404535016147BRAXM-AG16M
08404535016116BRAXM-PFC6R
08404535016086BRAXM-C6F
08404535016031BRAXM-C6R
08404535015997BRAXM-AG6L
08404535015966BRAXM-AG6S
08404535015935BRAXM-FP10LPR
08404535015904BRAXM-FP10L
08404535015874BRAXM-HP10M
08404535015843BRAXM-C5R
08404535015836BRAXM-FP10S
08404535015805BRAXM-HS10S
08404535015775BRAXM-HP10S
08404535015744BRAXM-FS8M
08404535015713BRAXM-HS8M
08404535015683BRAXM-HS8S
08404535015652BRAXM-FS8S
08404535015621BRAXM-FS6M
08404535015591BRAXM-HS6M
08404535015560BRAXM-FS6S
08404535015539BRAXM-HS6S

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