FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40198459028923
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKS1585
Catalog number
DYKS1585
Device description
PRE OP KIT
Published
2024-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
40198459028923PackageGS120In Commercial Distribution
10198459028922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845902892340198459028923
1019845902892210198459028922

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956392845CARDINAL HEALTHCardinal Health 200, LLCOJU2026-03-24
50198956392364CARDINAL HEALTHCardinal Health 200, LLCOJU2026-03-19
50198956326468CARDINAL HEALTHCardinal Health 200, LLCOJU2026-03-16
50198956377057CARDINAL HEALTHCardinal Health 200, LLCOJU2026-03-06
50198956301243CARDINAL HEALTHCardinal Health 200, LLCOJU2026-03-02
50198956387414CARDINAL HEALTHCardinal Health 200, LLCOJU2026-03-02
50198956387735CARDINAL HEALTHCardinal Health 200, LLCOJU2026-03-02
50198956346770CARDINAL HEALTHCardinal Health 200, LLCOJU2026-02-23
50198956318272CARDINAL HEALTHCardinal Health 200, LLCOJU2026-02-09
50198956280395CARDINAL HEALTHCardinal Health 200, LLCOJU2026-01-30
50198956178289CARDINAL HEALTHCardinal Health 200, LLCOJU2026-01-26
50198956326888CARDINAL HEALTHCardinal Health 200, LLCOJU2026-01-23
50198956258356CARDINAL HEALTHCardinal Health 200, LLCOJU2026-01-15
50198956178296CARDINAL HEALTHCardinal Health 200, LLCOJU2026-01-13
50198956275209CARDINAL HEALTHCardinal Health 200, LLCOJU2025-12-17
50198956299335CARDINAL HEALTHCardinal Health 200, LLCOJU2025-12-17
50198956228687CARDINAL HEALTHCardinal Health 200, LLCOJU2025-12-11
50198956253870CARDINAL HEALTHCardinal Health 200, LLCOJU2025-12-09
50198956259766CARDINAL HEALTHCardinal Health 200, LLCOJU2025-12-09
50198956259223CARDINAL HEALTHCardinal Health 200, LLCOJU2025-11-28
50198956274219CARDINAL HEALTHCardinal Health 200, LLCOJU2025-11-28
50198956234763CARDINAL HEALTHCardinal Health 200, LLCOJU2025-11-17
50198956232462CARDINAL HEALTHCardinal Health 200, LLCOJU2025-11-13
20809160504373Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OJU2025-11-13
50198956228021CARDINAL HEALTHCardinal Health 200, LLCOJU2025-11-11
40612479277555McKessonMCKESSON MEDICAL-SURGICAL INC.OJU2025-08-27
40612479277593McKessonMCKESSON MEDICAL-SURGICAL INC.OJU2025-08-27
40198459415679MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OJU2025-08-18
40198459477943MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OJU2025-08-18
40198459481667MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OJU2025-08-18