FDA.reportPublic FDA data

Scheker DRUJ

Primary DI
B013MITDRUJ1000
Brand
Scheker DRUJ
Company
APTIS MEDICAL, LLC
Model
MITDRUJ-100
Catalog number
MITDRUJ-100
Device description
Metal Instrument Tray, Distal Radioulnar Joint
Published
2021-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B013MITDRUJ1000PrimaryHIBCC0

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
10198956392977CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956449992CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956482401CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956499195CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956505513CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956507180CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956518438CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956518902CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956524934CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956524965CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956528772CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956528819CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956529137CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956531888CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956532519CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956532526CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956532892CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956380615CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956477384CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956497887CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956529175CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956529243CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956529304CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
00190446917861Arsenal FootTrilliant Surgical, LLCLRP2026-06-25
00190446917878Arsenal FootTrilliant Surgical, LLCLRP2026-06-25
00190446934417Arsenal FootTrilliant Surgical, LLCLRP2026-06-25
00190446934424Arsenal FootTrilliant Surgical, LLCLRP2026-06-25
00190446934431Arsenal FootTrilliant Surgical, LLCLRP2026-06-25
00190446934448Arsenal FootTrilliant Surgical, LLCLRP2026-06-25
00190446934455Arsenal FootTrilliant Surgical, LLCLRP2026-06-25