FDA.reportPublic FDA data

Counter Pusher, yellow

Primary DI
04250337119227
Brand
Counter Pusher, yellow
Company
Joimax GmbH
Model
CP28050
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
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250337119227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337119227042503371192274250337119227

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. 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
false
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
M739985202229Marking PinCAPTIVA SPINE, INC.FZX2026-10-28
M739985203229Marking PinCAPTIVA SPINE, INC.FZX2026-10-28
00889024702295OsseoFitZimmer, Inc.FZX2026-10-27
00889024702301OsseoFitZimmer, Inc.FZX2026-10-27
04250337119210Counter Pusher, greenJoimax GmbHFZX2026-10-27
04250337119234Counter Pusher, redJoimax GmbHFZX2026-10-27
M209232940Rose Proximal Cutting GuideBIOPRO, INC.FZX2026-10-27
M20923295Rose Distal Cutting GuideBIOPRO, INC.FZX2026-10-27
M739985202530Marking PinCAPTIVA SPINE, INC.FZX2026-10-23
M739985203530Marking PinCAPTIVA SPINE, INC.FZX2026-10-23
04250337117933Punching Adapter for Working TubeJoimax GmbHFZX2026-10-22
04250337119180Guiding Tube, eccentrically cannulated, redJoimax GmbHFZX2026-10-22
04250337119197Guiding Tube, eccentrically cannulated, purpleJoimax GmbHFZX2026-10-22
04250337119203Working Tube with Handle, oblique 45°Joimax GmbHFZX2026-10-22
04250337119562Guiding Tube, conicalJoimax GmbHFZX2026-10-22
04250337119579Guiding rod , conicalJoimax GmbHFZX2026-10-22
04250337119586Guiding rod , conicalJoimax GmbHFZX2026-10-22
04250337119593Working Tube with crown half teeth tipJoimax GmbHFZX2026-10-22
04250337119647Working Tube with handle, Standard lipJoimax GmbHFZX2026-10-22
04250337119678Guiding rod, conical, longitudinal slantedJoimax GmbHFZX2026-10-22
04250337119791Working Tube with long lipJoimax GmbHFZX2026-10-22
04250337120834Working tube, long lipJoimax GmbHFZX2026-10-22
04250337121862Working Tube with Handle, Standard LipJoimax GmbHFZX2026-10-22
04250337121909Working Tube with Handle, Standard LipJoimax GmbHFZX2026-10-22
04250337121916Working Tube with Handle, oblique 35°Joimax GmbHFZX2026-10-22
04250337121923Working Tube with Handle, oblique 35°Joimax GmbHFZX2026-10-22
04250337121930Working Tube with Handle, long lipJoimax GmbHFZX2026-10-22
04250337122029Guiding Rod, conicalJoimax GmbHFZX2026-10-22
04250337122036Guiding Rod, conical, greenJoimax GmbHFZX2026-10-22
00810055071210OviTex®TELA BIO, INC.FZX2026-10-21