FDA.reportPublic FDA data

Scheker DRUJ

Primary DI
B013DRUJT350
Brand
Scheker DRUJ
Company
APTIS MEDICAL, LLC
Model
DRUJ-T35
Catalog number
DRUJ-T35
Device description
3.5mm Quick Connect Tap
Published
2018-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HWXTap, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B013DRUJT350PrimaryHIBCC0

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
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
08800308479070ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HWX2026-08-19
08800308479094ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HWX2026-08-19
08800308479117ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HWX2026-08-19
00840606191883Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606191890Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606191906Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195782Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195799Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195805Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195812Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
07290019361343OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361350OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361367OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361374OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361381OSSIO® TapOSSIO LTDHWX2026-07-19
18257200076581CETRAOrthofix US LLCHWX2026-07-17
18257200076604CETRAOrthofix US LLCHWX2026-07-17
18257200076611CETRAOrthofix US LLCHWX2026-07-17
18257200076628CETRAOrthofix US LLCHWX2026-07-17
09120125220280Shark Screw® tapsurgebright GmbHHWX2026-04-30
10705034577913N/AMedos International SàrlHWX2026-04-23
10705034577920N/AMedos International SàrlHWX2026-04-23
10705034577937N/AMedos International SàrlHWX2026-04-23
10705034577944N/AMedos International SàrlHWX2026-04-23
10705034577951N/AMedos International SàrlHWX2026-04-23
10705034577968N/AMedos International SàrlHWX2026-04-23
10705034577975N/AMedos International SàrlHWX2026-04-23
10705034577982N/AMedos International SàrlHWX2026-04-23
10705034577999N/AMedos International SàrlHWX2026-04-23
G079C5020000950Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22