FDA.reportPublic FDA data

Scheker DRUJ

Primary DI
B013DRUJG1000
Brand
Scheker DRUJ
Company
APTIS MEDICAL, LLC
Model
DRUJ-G100
Catalog number
DRUJ-G100
Device description
Depth Gauge
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
HTJGauge, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTJGauge, DepthOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B013DRUJG1000PrimaryHIBCC0

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
08809513720045SAEHAN Hydraulic Pinch GaugeSaehan CorporationHTJ2026-05-18
08809513720359SAEHAN Mechanical Pinch GaugeSaehan CorporationHTJ2026-05-18
10850070500484Cannulated Depth Guage CURVAFIX, INC.HTJ2025-10-22
08800071006862Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
08809539690667Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
10840199512703Depth GaugeKOROS U.S.A., INC.HTJ2024-12-31
10840199513670Multi Level Black Belt Depth GaugeKOROS U.S.A., INC.HTJ2024-12-31
10885862573483EPICExactech, Inc.HTJ2024-01-08
07708604560472SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHTJ2023-01-18
08055727374561DEPTH GAUGE 9 mmHPF SRLHTJ2022-12-09
08055727374578DEPTH GAUGE 9 mmHPF SRLHTJ2022-12-09
10603295550273INHANCEDEPUY (IRELAND)HTJ2022-12-09
10855068008607Implant Selection DeviceCURVAFIX, INC.HTJ2022-12-05
10855068008331Implant Selection DeviceCURVAFIX, INC.HTJ2021-12-02
08800089415298INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089415328INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089417230INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089418350INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089418374INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089402762Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2021-05-28
08800089402779Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2021-05-28
08800089402830Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2021-05-28
M684E15000401EVOLUTIONMicroport Orthopedics Inc.HTJ2019-12-23
08806390873765VERUM System Surgical InstrumentJeil Medical CorporationHTJ2018-12-17
08806390863247Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2018-12-05
08806390865869Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2018-12-05
08806390867764Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2018-12-05
08806390857963VERUM System Surgical InstrumentJeil Medical CorporationHTJ2018-11-28
08806390859219VERUM System Surgical InstrumentJeil Medical CorporationHTJ2018-11-28
08806390860031VERUM System Surgical InstrumentJeil Medical CorporationHTJ2018-11-28