FDA.reportPublic FDA data

Crown Reamer red, fine, reusable

Primary DI
04250337114086
Brand
Crown Reamer red, fine, reusable
Company
Joimax GmbH
Model
CRF216575R
Published
2026-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250337114086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337114086042503371140864250337114086

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49721255140info@joimax.com

Regulatory Flags#

DUNS number
344267187
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250337118985J-Needle Navi WL 120, trocar, 11 GJINTJT1230102026-10-28
04250337119661Endo-Kerrison ShaftEKS245555402026-10-28
04250337120674Inner Drill Reamer 4.0 mm, cannulatedDRC2440242026-10-28
04250337120681Outer Drill, bluntDRC227341B2026-10-28
04250337120698Outer Drill, crownDRC227341C2026-10-28
04250337120810Inner Drill Reamer 4,0 mm, kanülliert, reusableDRC244024R2026-10-28
04250337120872Camera Head Ocular for Camsource® DuoCSD4K01CO2026-10-28
04250337120988Optic CouplerCSD4K01COV2026-10-28
04250337120995Fibre optic cableCSLC02502026-10-28
04250337121008Fiber Optic Cable Adapter joimax/WolfCSLC0250.L12026-10-28
04250337121817Endo-Kerrison ShaftEKS246550402026-10-28
04250337121879CuretteDEC2645122026-10-28
04250337121992DissectorJDA264519C2026-10-28
04250337122104iLESSYS® Delta Access TrayTDT502550DL-12026-10-28
04250337122111iLESSYS® Delta Resection TrayTDT502550DL-22026-10-28
04250337106784Percusys® PlusJMPP0535MSJMPP0535MS2020-01-03
04250337106791Percusys® PlusJMPP0540MSJMPP0540MS2020-01-03
04250337106807Percusys® PlusJMPP0545MSJMPP0545MS2020-01-03
04250337106814Percusys® PlusJMPP0550MSJMPP0550MS2020-01-03
04250337106821Percusys® PlusJMPP0635MSJMPP0635MS2020-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337120674Inner Drill Reamer 4.0 mm, cannulatedJoimax GmbHHTO2026-10-28
04250337120681Outer Drill, bluntJoimax GmbHHTO2026-10-28
04250337120698Outer Drill, crownJoimax GmbHHTO2026-10-28
04250337120810Inner Drill Reamer 4,0 mm, kanülliert, reusableJoimax GmbHHTO2026-10-28
00889024702264OsseoFitZimmer, Inc.HTO2026-10-27
00889024702271OsseoFitZimmer, Inc.HTO2026-10-27
00889024702318OsseoFitZimmer, Inc.HTO2026-10-27
00889024702325OsseoFitZimmer, Inc.HTO2026-10-27
00889024702332OsseoFitZimmer, Inc.HTO2026-10-27
00889024702349OsseoFitZimmer, Inc.HTO2026-10-27
04250337119609Crown Reamer red, fine, reusableJoimax GmbHHTO2026-10-27
10810128463918VersiTomic RR Retrograde Reamer 4.5 x 10.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
00810112598537DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598544DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598551DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598568DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598575DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598599DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598605DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598612DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598629DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598636DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112592269TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592276TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592283TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592290TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592306TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592313TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592320TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592337TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23