FDA.reportPublic FDA data

Axiom Blades

Primary DI
08404535024401
Brand
Axiom Blades
Company
Peter Brasseler Holdings, LLC
Model
BRAXM-FP8M
Catalog number
BRAXM-FP8M
Device description
BRAXM-FP8M FULL PIERCER 8X190MM
Published
2026-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZVSystem, cement removal extraction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZVSystem, Cement Removal ExtractionOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08404535024401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08404535024401084045350244018404535024401

GMDN Terms#

Term, Definition table
TermDefinition
Hard/soft-tissue ultrasonic surgical systemAn assembly of devices designed to use ultrasonic energy to mechanically fragment and cut bone and soft tissue, and possibly bone cement during an orthopaedic surgical procedure (e.g., arthroplasty revision, spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It typically includes an ultrasonic energy-producing generator, a handpiece with cutting tip(s)/probe(s) to apply the energy and remove (aspirate) material, and connecting cables.

Regulatory Flags#

DUNS number
082080136
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887919170488Brasseler USA Sterile Carbide000388SP000388SP2026-05-27
00887919227335Brasseler USA Sterile Diamond004878SP004878SP2026-05-27
00887919317036Brasseler USA Sterile Diamond017274SP017274SP2026-05-27
08404535029468Brasseler USA Sterile Diamond004164SP004164SP2026-05-27
08404535029499Brasseler USA Sterile Diamond004325SP004325SP2026-05-27
08404535029529Brasseler USA Sterile Diamond004529SP004529SP2026-05-27
08404535029550Brasseler USA Sterile Diamond004801SP004801SP2026-05-27
08404535029581Brasseler USA Sterile Diamond004818SP004818SP2026-05-27
08404535029611Brasseler USA Sterile Diamond004820SP004820SP2026-05-27
08404535029642Brasseler USA Sterile Diamond004868SP004868SP2026-05-27
08404535029673Brasseler USA Sterile Diamond004959SP004959SP2026-05-27
08404535029703Brasseler USA Sterile Diamond005034SP005034SP2026-05-27
08404535029734Brasseler USA Sterile Diamond005043SP005043SP2026-05-27
08404535029765Brasseler USA Sterile Diamond005046SP005046SP2026-05-27
08404535029796Brasseler USA Sterile Diamond005056SP005056SP2026-05-27
08404535029826Brasseler USA Sterile Diamond005255SP005255SP2026-05-27
08404535029857Brasseler USA Sterile Diamond005256SP005256SP2026-05-27
08404535029888Brasseler USA Sterile Diamond005372SP005372SP2026-05-27
08404535029918Brasseler USA Sterile Diamond012223SP012223SP2026-05-27
08404535029949Brasseler USA Sterile Diamond013287SP013287SP2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535024227Axiom BladesPeter Brasseler Holdings, LLCLZV2026-04-29
08404535024258Axiom BladesPeter Brasseler Holdings, LLCLZV2026-04-29
08404535024289Axiom BladesPeter Brasseler Holdings, LLCLZV2026-04-29
08404535024319Axiom BladesPeter Brasseler Holdings, LLCLZV2026-04-29
08404535024340Axiom BladesPeter Brasseler Holdings, LLCLZV2026-04-29
08404535024371Axiom BladesPeter Brasseler Holdings, LLCLZV2026-04-29
08404535022452Axiom BladesPeter Brasseler Holdings, LLCLZV2025-12-10
08404535022483Axiom BladesPeter Brasseler Holdings, LLCLZV2025-12-10
08404535022506Axiom BladesPeter Brasseler Holdings, LLCLZV2025-12-10
08404535022568Axiom BladesPeter Brasseler Holdings, LLCLZV2025-12-10
08404535022599Axiom BladesPeter Brasseler Holdings, LLCLZV2025-12-10
08404535022629Axiom BladesPeter Brasseler Holdings, LLCLZV2025-12-10
08404535022650Axiom BladesPeter Brasseler Holdings, LLCLZV2025-12-10
08404535022681Axiom BladesPeter Brasseler Holdings, LLCLZV2025-12-10
08404535019278Axiom BladesPeter Brasseler Holdings, LLCLZV2025-07-28
08404535019308Axiom BladesPeter Brasseler Holdings, LLCLZV2025-07-28
08404535015539Axiom BladesPeter Brasseler Holdings, LLCLZV2025-05-31
08404535015560Axiom BladesPeter Brasseler Holdings, LLCLZV2025-05-31
08404535015591Axiom BladesPeter Brasseler Holdings, LLCLZV2025-05-31
08404535015621Axiom BladesPeter Brasseler Holdings, LLCLZV2025-05-31
08404535015652Axiom BladesPeter Brasseler Holdings, LLCLZV2025-05-31
08404535015683Axiom BladesPeter Brasseler Holdings, LLCLZV2025-05-31
08404535015713Axiom BladesPeter Brasseler Holdings, LLCLZV2025-05-31
08404535015744Axiom BladesPeter Brasseler Holdings, LLCLZV2025-05-31
08404535015775Axiom BladesPeter Brasseler Holdings, LLCLZV2025-05-31
08404535015805Axiom BladesPeter Brasseler Holdings, LLCLZV2025-05-31
08404535015836Axiom BladesPeter Brasseler Holdings, LLCLZV2025-05-31
08404535015843Axiom BladesPeter Brasseler Holdings, LLCLZV2025-05-31
08404535015874Axiom BladesPeter Brasseler Holdings, LLCLZV2025-05-31
08404535015904Axiom BladesPeter Brasseler Holdings, LLCLZV2025-05-31