FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327670642
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ86736
Catalog number
DYNJ86736
Device description
MAJOR BREAST SJF-LF
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
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTNPlastic surgery and accessories kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTNPlastic Surgery And Accessories KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327670642PackageGS12In Commercial Distribution
10195327670641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532767064240195327670642
1019532767064110195327670641

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
10080196920846Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2025-01-19
10193489425918Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-07-29
10193489434392Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-07-29
10193489214390Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489214475Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489215519Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489406696Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489414936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489416138Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489416183Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489418828Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419399Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419450Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419597Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419726Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419733Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489421743Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489424171Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489424850Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489426311Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489427073Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489429114Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489429299Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489429305Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489439175Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489441352Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489441635Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489442670Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489442687Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08