FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10195327574918
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ903423J
Catalog number
DYNJ903423J
Device description
MAJOR HEAD NECK
Published
2023-12-17
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
OGREar, nose, and throat surgical tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGREar, Nose, And Throat Surgical TrayEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10195327574918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019532757491810195327574918

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
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
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
10080196884704Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2025-01-19
10193489212303Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2023-06-08
10193489212877Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2023-06-08
H65857031985Henry ScheinHENRY SCHEIN, INC.OGR2022-09-19
10193489063912Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-19
10193489287547Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489288261Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489290424Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489290691Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489290783Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489290912Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489292008Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489292015Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489292497Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489292503Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489292596Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489293371Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489293401Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489294118Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489294682Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489294699Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489294767Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489295856Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489295894Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489296907Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489297287Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489299120Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489299977Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489300598Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489301564Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09