FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327028450
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ52141B
Catalog number
DYNJ52141B
Device description
COLON WOUND CLOSURE PACK
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCYWound dressing kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCYWound Dressing KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327028450PackageGS16In Commercial Distribution
10195327028459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532702845040195327028450
1019532702845910195327028459

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
false
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
10198459428623MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MCY2025-07-21
10198459433474MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MCY2025-07-21
10198459171789Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-11-24
10653160381518MEDLINEMEDLINE INDUSTRIES, INC.MCY2024-10-28
10198459057939Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-10-20
10195327657833Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-07-29
10195327667924Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-07-29
10198459053849Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-06-30
10195327559182Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-12-21
10193489360479Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
10193489417005Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
10193489417043Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
10195327421298Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
10195327297725Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-13
10193489398335Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489398427Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489399820Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489399929Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489411560Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489416954Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489418286Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489418385Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489418392Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489418408Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489420982Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489421088Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489421606Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489423600Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489432121Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
10193489432138Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08