FDA.reportPublic FDA data

KOHDENT

Primary DI
04251436920370
Brand
KOHDENT
Company
Kohler Medizintechnik GmbH
Model
6660
Catalog number
6660
Device description
BONE-MILL-bone crusher-TITANIUM-tips
Published
2021-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
04251436920370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251436920370042514369203704251436920370

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

Contacts#

Phone, Email table
PhoneEmail
+497771649990info@kohler-medizintechnik.de

Regulatory Flags#

DUNS number
344386737
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251436919084Kohler6414-CC2026-04-23
04251436943850Kohler83142026-04-23
04251436909030KOHLER451645162026-03-12
04251436934155KOHLER451645162026-03-12
04251436931086KOHLER955795572026-03-12
04251436943805KOHLER842884282026-03-12
04251436943812KOHLER8461-CC8461-CC2026-03-12
04251436943836KOHLER8401-N8401-N2026-03-12
04251436943843KOHLER330833082026-03-12
04251436907746KOHDENT430643062021-08-30
04251436943492KOHDENT670067002023-11-28
04251436915819KOHDENT573957392021-09-22
04251436915826KOHDENT574057402021-09-22
04251436915833KOHDENT574157412021-09-22
04251436918094KOHDENT616361632021-09-22
04251436918100KOHDENT616661662021-09-22
04251436918179KOHDENT620962092021-09-22
04251436918186KOHDENT621062102021-09-22
04251436918834KOHDENT635863582021-09-22
04251436921209KOHDENT679267922021-09-22

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
08720254007847HandleSpierings 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