FDA.reportPublic FDA data

Scheker DRUJ

Primary DI
B013DRUJH1000
Brand
Scheker DRUJ
Company
APTIS MEDICAL, LLC
Model
DRUJ-H100
Catalog number
DRUJ-H100
Device description
Quick Connect Handle
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B013DRUJH1000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
780455338
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B013DRUJI100Scheker DRUJDRUJ-I100DRUJ-I1002018-09-24
B013DRUJKW450Scheker DRUJDRUJ-KW45DRUJ-KW542023-06-08
B013DRUJKW540Scheker DRUJDRUJ-KW54DRUJ-KW542021-11-26
B013DRUJLSC100NADRUJ-LSC10DRUJ-LSC102021-08-27
B013DRUJLSC120NADRUJ-LSC12DRUJ-LSC122021-08-27
B013DRUJLSC140NADRUJ-LSC14DRUJ-LSC142021-08-27
B013DRUJLSC160NADRUJ-LSC16DRUJ-LSC162021-08-27
B013DRUJLSC180NADRUJ-LSC18DRUJ-LSC182021-08-27
B013DRUJLSC200NADRUJ-LSC20DRUJ-LSC202021-08-27
B013DRUJLSC220NADRUJ-LSC22DRUJ-LSC222021-08-27
B013DRUJLSC240NADRUJ-LSC24DRUJ-LSC242021-08-27
B013DRUJSC100NADRUJ-SC10DRUJ-SC102021-08-27
B013DRUJSC120NADRUJ-SC12DRUJ-SC122021-08-27
B013DRUJSC140NADRUJ-SC14DRUJ-SC142021-08-27
B013DRUJSC160NADRUJ-SC16DRUJ-SC162021-08-27
B013DRUJSC180NADRUJ-SC18DRUJ-SC182021-08-27
B013DRUJSC200NADRUJ-SC20DRUJ-SC202021-08-27
B013DRUJSC220NADRUJ-SC22DRUJ-SC222021-08-27
B013DRUJSC240NADRUJ-SC24DRUJ-SC242021-08-27
B013DRUJSD150Scheker DRUJDRUJ-SD15DRUJ-SD152024-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221373076PERLA ® TLSpineArt SAHXX2026-05-07
09120125220259Shark Screw® driver aclsurgebright GmbHHXX2026-04-30
08806373894213LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373899720LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373887789BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
08806373892660BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
07640332475294PERLA ®SpineArt SAHXX2025-11-10
07640332475300PERLA ®SpineArt SAHXX2025-11-10
07640332475317PERLA ®SpineArt SAHXX2025-11-10
08059386744253Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-06
08059386742266Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-05
09348215164737Turbine X Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164744Turbine X Driver – RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164751MI (Mini Incision) Driver - RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164768MI (Mini Incision) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164775O (Turbine OP) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151650172.9 Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165024Vector Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151651235.5 Knotless DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165130Screw DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165178Simple Driver (Black)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165185Simple Driver (Orange)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165208Tendonesis Chamfer ReamerSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165284Staple ShaftSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
G791CDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
G791SDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
09120125220037Shark Screw® couplingsurgebright GmbHHXX2025-09-16
09120125220228Shark Screw® driversurgebright GmbHHXX2025-09-16
08800071006848Surgical InstrumentOSTEONIC CO.,Ltd.HXX2025-06-24
08800071024248SignexOSTEONIC CO.,Ltd.HXX2025-06-24