FDA.reportPublic FDA data

Handle

Primary DI
08720254007847
Brand
Handle
Company
Spierings Orthopaedics B.V.
Model
SMT-SBM-9801-06
Published
2023-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LYSBone Mill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYSBone MillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720254007847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720254007847087202540078478720254007847

GMDN Terms#

Term, Definition table
TermDefinition
Manual bone millA manually-operated, non-patient-contact device intended to be used to grind bone into a slurry or a powder for use as a bone matrix for bone regeneration or bone grafting. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
407288690
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720828234181KINCISE™ System Acetabular Cup Extraction Case Standard SetKIN-2110-062000051002024-03-26
08720828234198KINCISE™ System Acetabular Cup Extraction Case Outlier SetKIN-2110-072000052002024-03-26
08720254007472KINCISE™ System Acetabular Cup Extraction Finisher Blade 44mmKIN-2110-44F-SU2000052442024-03-20
08720254007489KINCISE™ System Acetabular Cup Extraction Finisher Blade 46mmKIN-2110-46F-SU2000052462024-03-20
08720254007496KINCISE™ System Acetabular Cup Extraction Finisher Blade 48mmKIN-2110-48F-SU2000052482024-03-20
08720254007502KINCISE™ System Acetabular Cup Extraction Finisher Blade 50mmKIN-2110-50F-SU2000052502024-03-20
08720254007519KINCISE™ System Acetabular Cup Extraction Finisher Blade 52mmKIN-2110-52F-SU2000052522024-03-20
08720254007526KINCISE™ System Acetabular Cup Extraction Finisher Blade 54mmKIN-2110-54F-SU2000052542024-03-20
08720254007533KINCISE™ System Acetabular Cup Extraction Finisher Blade 56mmKIN-2110-56F-SU2000052562024-03-20
08720254007540KINCISE™ System Acetabular Cup Extraction Finisher Blade 58mmKIN-2110-58F-SU2000052582024-03-20
08720254007557KINCISE™ System Acetabular Cup Extraction Finisher Blade 60mmKIN-2110-60F-SU2000052602024-03-20
08720254007564KINCISE™ System Acetabular Cup Extraction Finisher Blade 62mmKIN-2110-62F-SU2000052622024-03-20
08720254007571KINCISE™ System Acetabular Cup Extraction Finisher Blade 64mmKIN-2110-64F-SU2000052642024-03-20
08720254007588KINCISE™ System Acetabular Cup Extraction Finisher Blade 66mmKIN-2110-66F-SU2000052662024-03-20
08720254007595KINCISE™ System Acetabular Cup Extraction Finisher Blade 68mmKIN-2110-68F-SU2000052682024-03-20
08720254007007KINCISE™ System Acetabular Cup Extraction ShaftKIN-2110-012000050002024-03-19
08720254007014KINCISE™ System Acetabular Cup Extraction BoltKIN-2110-042000050152024-03-19
08720254007021KINCISE™ System Acetabular Cup Extraction Hex KeyKIN-2110-052000050162024-03-19
08720254007038KINCISE™ System Acetabular Cup Extraction WrenchKIN-2110-022000050172024-03-19
08720254007069KINCISE™ System Acetabular Cup Extraction SST Head 26mmKIN-2110-26-SS2000050262024-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B504BM54007010000StrykerProvisionLYS2024-09-16
00889024675346Z1™ Hip SystemZimmer, Inc.LYS2024-09-09
00889024675353Z1™ Hip SystemZimmer, Inc.LYS2024-09-09
00889024675360Z1™ Hip SystemZimmer, Inc.LYS2024-09-09
B504BMBM2100MedtronicProvisionLYS2024-06-11
04047844121368DIPLOMATSIGNUS Medizintechnik GmbHLYS2024-06-05
00842517106253Karl SchumacherKarl Schumacher Dental, LLCLYS2024-02-27
10603295516378NADEPUY ORTHOPAEDICS, INC.LYS2024-01-15
00614950031252ACEACE SURGICAL SUPPLY CO., INC.LYS2023-12-05
00888118142924BONE MILLKLS-Martin L.P.LYS2023-11-22
00888118142931BONE MILLKLS-Martin L.P.LYS2023-11-22
00888118142948BONE MILLKLS-Martin L.P.LYS2023-11-22
00888118142955BONE MILLKLS-Martin L.P.LYS2023-11-22
00888118142962BONE MILLKLS-Martin L.P.LYS2023-11-22
00841336103399Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCLYS2023-08-10
00841336103504Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCLYS2023-08-10
00888118142597BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142603BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142610BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142627BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142634BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142641BONE MILLKLS-Martin L.P.LYS2023-07-04
00888118142658BONE MILLKLS-Martin L.P.LYS2023-07-04
00190776264055AvalignAvalign Technologies, Inc.LYS2023-06-23
08720254007816Sterilization tray NBMSpierings Orthopaedics B.V.LYS2023-06-20
08720254007823HousingSpierings Orthopaedics B.V.LYS2023-06-20
08720254007830Push BlockSpierings Orthopaedics B.V.LYS2023-06-20
08720254007854Screw nutSpierings Orthopaedics B.V.LYS2023-06-20
08720254007861Milling Drum Extra Extra Extra FineSpierings Orthopaedics B.V.LYS2023-06-20
08720254007878Milling Drum Extra Extra FineSpierings Orthopaedics B.V.LYS2023-06-20