FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10195327369200
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKMBNDL43B
Catalog number
DYKMBNDL43B
Device description
KIT SURG ONC PORT INSERTION
Published
2023-06-13
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
OJKEye tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327369201PackageGS16In Commercial Distribution
10195327369200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532736920140195327369201
1019532736920010195327369200

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489024517MEDLINEMDS601LSQHFEMDS601LSQHFE2026-07-22
10888277348141MEDLINEMDS601P2MDS601P22026-07-22
10884389145517MEDLINEMDS630BSQMDS630BSQ2016-09-27
10884389145722MEDLINEMDS630LSQMDS630LSQ2016-10-14
10884389145739MEDLINEMDS630MSQMDS630MSQ2016-10-14
10884389818794MEDLINEMDS630XSQMDS630XSQ2016-09-27
20080196162410MEDLINEMPHADJDEPTH2MPHADJDEPTH22023-01-21
10080196395811MEDLINEMPH100030MPH1000302026-07-22
10653160393979MEDLINEDYNDC3596DYNDC35962026-07-21
10653160394051MEDLINEDYNDC3606DYNDC36062026-07-21
10653160394082MEDLINEDYNDC3613DYNDC36132026-07-21
10653160394099MEDLINEIV8880AIV8880A2026-07-21
10653160394105MEDLINEECVC8651ECVC86512026-07-21
10653160394112MEDLINEDYNDC3597DYNDC35972026-07-21
10653160394129MEDLINEDYNDC3611DYNDC36112026-07-21
10653160394150MEDLINEDYNDJ1156DYNDJ11562026-07-21
10653160394167MEDLINEDYNDV2742ADYNDV2742A2026-07-21
10653160394174MEDLINEECVC8390CECVC8390C2026-07-21
10653160394181MEDLINEEBSI1477CEBSI1477C2026-07-21
10653160394211MEDLINEDYNDC3605DYNDC36052026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS131930Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-22
B098AMS14577A0Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-22
10198956363960CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956385535CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956417434CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956418622CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956484986CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956489882CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956498495CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956518513CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956526013CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956529069CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956531222CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956532175CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956532694CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956533820CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956533981CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
B098AMS192180Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-19
10198956382930CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956390546CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956516335CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956519626CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956529441CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956530584CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
B098AMS193400Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-12
10198956339132CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956391949CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956394247CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956414532CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956423213CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09