FDA.reportPublic FDA data

Axiom Blades

Primary DI
08404535024340
Brand
Axiom Blades
Company
Peter Brasseler Holdings, LLC
Model
BRAXM-HP8S
Catalog number
BRAXM-HP8S
Device description
BRAXM-HP8S HALF PIERCER 8X100MM
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
08404535024340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08404535024340084045350243408404535024340

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
08404535023398Brasseler USA5031885U05031885U02026-05-13
08404535029406Brasseler USA5032304U05032304U02026-05-13
08404535029437Brasseler USA5032305U05032305U02026-05-13
08404535025101Brasseler USA5032020U05032020U02026-05-11
08404535025927Brasseler USA5032032U05032032U02026-05-01
08404535015003Brasseler USA5031791U05031791U02026-04-29
08404535015126Brasseler USA5031795U05031795U02026-04-29
08404535018929Brasseler USA5031818U05031818U02026-04-29
08404535018950Brasseler USA5031819U05031819U02026-04-29
08404535019049Brasseler USA5031822U05031822U02026-04-29
08404535019070Brasseler USA5031823U05031823U02026-04-29
08404535019100Brasseler USA5031824U05031824U02026-04-29
08404535019131Brasseler USA5031825U05031825U02026-04-29
08404535019162Brasseler USA5031826U05031826U02026-04-29
08404535024227Axiom BladesBRAXM-GP8BRAXM-GP82026-04-29
08404535024258Axiom BladesBRAXM-FP14MBRAXM-FP14M2026-04-29
08404535024289Axiom BladesBRAXM-FC6BRAXM-FC62026-04-29
08404535024319Axiom BladesBRAXM-FP8SBRAXM-FP8S2026-04-29
08404535024371Axiom BladesBRAXM-HP8MBRAXM-HP8M2026-04-29
08404535024401Axiom BladesBRAXM-FP8MBRAXM-FP8M2026-04-29

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
08404535024371Axiom BladesPeter Brasseler Holdings, LLCLZV2026-04-29
08404535024401Axiom 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