FDA.reportPublic FDA data

Wing Handle for Reamer

Primary DI
04250337114024
Brand
Wing Handle for Reamer
Company
Joimax GmbH
Model
RHD101236
Device description
Handles are non-invasive surgical instruments, used as handles in combination with invasive surgical instruments to operate (e.g. move, turn or direct) these instruments in order to exert their function at the area of interest during surgery and therefore qualify as medical devices.Handles are reusable medical devices made of materials appropriate for processing like medical grade silicone or medical-grade stainless steel.
Published
2025-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04250337114024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337114024042503371140244250337114024

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
344267187
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250337117384video lensCSFHD01COVZCSFHD01COVZ2022-12-30
04260744830561Fibre optic cableCSLC0348CSLC03482022-12-30
04260744831865Fibre optic cableCSLC0252CSLC02522022-12-30
04250337119876Sterilisation trayJSBDSST4680JSBDSST46802022-12-30
04250337110040intENTS®TNC582810GTNC582810G2022-12-30
04250337110057MultiZYTE®TNC582814GTNC582814G2022-12-30
04250337110064iLESSYS®TNC582820RTNC582820R2022-12-30
04250337113041TESSYS®TNC582820TNC5828202022-12-30
04250337117537tubTNC5828100TNC58281002022-12-30
04250337117544tubTNC5828135TNC58281352022-12-30
04250337117551tubTNC5828150TNC58281502022-12-30
04250337117568tubTNC5828200TNC58282002022-12-30
04250337117575iLESSYS®TNC5828CLTNC5828CL2022-12-30
04250337117582iLESSYS®TNC5828ILTNC5828IL2022-12-30
04250337117599iLESSYS®TNC5828MLTNC5828ML2022-12-30
04250337117605iLESSYS®TNC5828NLTNC5828NL2022-12-30
04250337117612iLESSYS®TNC5828TLTNC5828TL2022-12-30
04250337117827iLESSYS®TNC5828ALTNC5828AL2022-12-30
04250337120759deflectorJSBS311509JSBS3115092025-07-25
04250337120766deflectorJSBS311512JSBS3115122025-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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