FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10195327263133
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKS1405
Catalog number
DYKS1405
Device description
PRE OP KIT
Published
2022-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJUSkin prep tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJUSkin Prep TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327263134PackageGS160In Commercial Distribution
10195327263133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532726313440195327263134
1019532726313310195327263133

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489135909MEDLINEDYNJP2228SGDYNJP2228SG2026-07-17
10197344112722MEDLINESSBCS23GTSSBCS23GT2026-07-17
10197344157174MEDLINESNAPSECUREPSNAPSECUREP2026-07-17
10197344169450MEDLINEMSCSRG9736MSCSRG97362026-07-17
10197344205141MEDLINEMSC608ASXLMSC608ASXL2026-07-17
10197344216116MEDLINESSBCS21GSSBCS21G2026-07-17
10197344216130MEDLINESSBCS21GTSSBCS21GT2026-07-17
10197344216147MEDLINESSBCS23GSSBCS23G2026-07-17
10197344216154MEDLINESSBCS23GLSSBCS23GL2026-07-17
10197344216161MEDLINESSBCS25GSSBCS25G2026-07-17
10197344216178MEDLINESSBCS25GLSSBCS25GL2026-07-17
10197344216185MEDLINESSBCS25GTSSBCS25GT2026-07-17
10884389362020MEDLINEDYNJSMD01DYNJSMD012026-07-17
10888277407954MEDLINEOR87VOR87V2026-07-17
20193489029939MEDLINEMDTZ1020872GHMDTZ1020872GH2026-07-17
20193489029953MEDLINEMDTZ1020872GJMDTZ1020872GJ2026-07-17
20197344033925MEDLINEMLABDISH35MLABDISH352026-07-17
20197344033956MEDLINEMLABDISH65MLABDISH652026-07-17
20197344219428MEDLINEMDT2168054XGVMDT2168054XGV2026-07-17
20197344219442MEDLINEMDT2168104GVMDT2168104GV2026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10195327428433Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-12-21
10195327435981Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-08-20
10195327242664Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327261627Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327421830Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327427382Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327428228Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327432614Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327445973Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327440282Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-23
10195327437534Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-25
10195327439620Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-25
10195327238445Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327267025Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327268046Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327269197Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327272012Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327272555Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327277093Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327277284Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327277925Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327278922Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327279004Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327280567Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327285517Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327285654Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327297602Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327298753Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327340643Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327342722Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13