FDA.reportPublic FDA data

Scheker DRUJ

Primary DI
B013DRUJKW540
Brand
Scheker DRUJ
Company
APTIS MEDICAL, LLC
Model
DRUJ-KW54
Catalog number
DRUJ-KW54
Device description
"K-Wire D. TROCAR .054"""
Published
2021-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
B013DRUJKW540PrimaryHIBCC0

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
DM exempt
true
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
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
B013DRUJK100B0Scheker DRUJDRUJ-K100BDRUJ-K100B2018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008100978037493.0mm GUIDE WIRE 355mmOsteocentric Technologies, Inc.FZX2026-06-02
00889024707382Persona Tensor Sizer Arm – LongZimmer, Inc.FZX2026-05-29
00889024707399Persona Tensor Sizer Arm – StdZimmer, Inc.FZX2026-05-29
00889024707405Persona Tensor Sizer BodyZimmer, Inc.FZX2026-05-29
G079INL1160070Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
G079INL1160120Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
08806373887772BENCOX Surgical InstrumentsCorentec Co., LtdFZX2026-01-12
08800089479375Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2025-12-04
07640332475348CURE 2.0 ACPSpineArt SAFZX2025-11-12
07640375235732PERLA ® TL MISSpineArt SAFZX2025-11-10
G79153202001620G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
G79153202021615G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
08800071017462Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017479Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017486Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017493Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017509Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017516Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017523Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084389Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084396Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084402Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084419Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084426Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084433Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
G463090799PK0Spine InstrumentsBOXSPINE HOLDINGS, INC.FZX2025-01-16
008101182101673.7mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
008101182101744.2mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
008101182101815.5mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
08800089436033Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17