FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327338894
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ44331F
Catalog number
DYNJ44331F
Device description
ENT PACK
Published
2023-02-12
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
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
40195327338894PackageGS16In Commercial Distribution
10195327338893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532733889440195327338894
1019532733889310195327338893

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
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
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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
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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