FDA.reportPublic FDA data

Diamond Abrasor, Ball Tip, Coarse

Primary DI
04250337120131
Brand
Diamond Abrasor, Ball Tip, Coarse
Company
Joimax GmbH
Model
JSBDA275554C
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
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250337120186PackageGS15Not in Commercial Distribution
04250337120131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337120186042503371201864250337120186
04250337120131042503371201314250337120131

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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250337118855TESSYS® Crown Reamer, orange, fineCRF2160702026-11-03
04250337119173Awl, without HandleTEA3224002026-11-04
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
04250337120704Diamond Abrasor, Ball TipJoimax GmbHHWE2026-11-03
04250337122333Olive Cutter, Olive Tip, with side protectionJoimax GmbHHWE2026-11-03
00763000777418CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-11-01
00763000777517CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-11-01
00763000777524CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-11-01
00763000774165CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774172MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774189MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774196MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774202MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774226MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774240MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774257MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774301MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000777692MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000777739MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
09421038413753Enztec Modular Planer Handle - ZimmerENZTEC LIMITEDHWE2026-10-30
09421038413760Enztec Modular Planer Handle - Large AOENZTEC LIMITEDHWE2026-10-30
09421038413777Enztec Modular Planer Handle - HudsonENZTEC LIMITEDHWE2026-10-30
09421038413784Enztec Modular Planer 38mm – 7.10mm IDENZTEC LIMITEDHWE2026-10-30
09421038413791Enztec Modular Planer 38mm – 8.00mm IDENZTEC LIMITEDHWE2026-10-30
09421038413807Enztec Modular Planer 45mm – 7.10mm IDENZTEC LIMITEDHWE2026-10-30
09421038413814Enztec Modular Planer 45mm – 8.00mm IDENZTEC LIMITEDHWE2026-10-30
09421038413821Enztec Modular Planer 45mm – 8.10mm IDENZTEC LIMITEDHWE2026-10-30
09421038413838Enztec Modular Planer 38mm – 8.10mm IDENZTEC LIMITEDHWE2026-10-30
04250337121794"Shrill® Deflector Shaft 2, WL= 320mm, reusable"Joimax GmbHHWE2026-10-29
04250337122388Deflector Bone Resector, Bullet-Tip, disposableJoimax GmbHHWE2026-10-29
04250337122395Deflector Diamond Abrasor, disposableJoimax GmbHHWE2026-10-29
04250337122401Deflector Bone Resector, Ball-Tip, disposableJoimax GmbHHWE2026-10-29
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-25