FDA.reportPublic FDA data

TESSYS® Crown Reamer, orange, fine

Primary DI
04250337118855
Brand
TESSYS® Crown Reamer, orange, fine
Company
Joimax GmbH
Model
CRF216070
Published
2026-11-03
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
04250337118862PackageGS15In Commercial Distribution
04250337118855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337118862042503371188624250337118862
04250337118855042503371188554250337118855

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
04250337119173Awl, without HandleTEA3224002026-11-04
04250337120131Diamond Abrasor, Ball Tip, CoarseJSBDA275554C2026-11-03
04250337120704Diamond Abrasor, Ball TipJSBDA324544C2026-11-03
04250337122333Olive Cutter, Olive Tip, with side protectionJSBOC2755432026-11-03
042503371190364K UHD Laminoscope (4.7 WCh), comboLS7347150C-4K2026-11-02
042503371190434K UHD Laminoscope (4.7 WCh), ocularLS7347150O-4K2026-11-02
042503371191354K UHD Laminoscope (4.7 WCh), ocularLS7347068O-4K2026-11-02
042503371191424K UHD Laminoscope (4.7 WCh), comboLS7347068C-4K2026-11-02
042503371191594K UHD Foraminoscope (4.7 WCh), comboFS7347171C-4K2026-11-02
042503371191664K UHD Foraminoscope (4.7 WCh), ocularFS7347171O-4K2026-11-02
04250337100942Sealing CapSCLL15202026-10-29
04250337112860Closing Cap for joimax® endoscopesTCC2008052026-10-29
04250337118831joimax® Vitegra® Foot SwitchJVFS00012026-10-29
04250337120308Biportal Laminoscope, okularBS4015175O-4K2026-10-29
04250337120605Biportal Laminoscope, okularBS4000175O-4K2026-10-29
04250337120643Biportal Laminoscope, okularBS4030175O-4K2026-10-29
04250337120971Camsource® Duo Control UnitCSD4K012026-10-29
04250337121053Endoscope Adapter for iLESSYS® Delta LaminoscopeRFEAID10A2026-10-29
04250337121060Coupling nut for endoscope adapterRFEACS2026-10-29
04250337121077Adapter holderRFADH2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842078102794IO FiXEXTREMITY MEDICAL, LLCHTO2026-10-29
00842078102800IO FiXEXTREMITY MEDICAL, LLCHTO2026-10-29
00842078102817IO FiXEXTREMITY MEDICAL, LLCHTO2026-10-29
00842078107959XMCPEXTREMITY MEDICAL, LLCHTO2026-10-29
00842078114780Omni MTPEXTREMITY MEDICAL, LLCHTO2026-10-29
00842078115626Jones UnionEXTREMITY MEDICAL, LLCHTO2026-10-29
00842078115633Jones UnionEXTREMITY MEDICAL, LLCHTO2026-10-29
00842078115640Jones UnionEXTREMITY MEDICAL, LLCHTO2026-10-29
00842078115671KinematX TotalEXTREMITY MEDICAL, LLCHTO2026-10-29
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
04250337114086Crown Reamer red, fine, reusableJoimax GmbHHTO2026-10-27
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