FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327578634
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ55826A
Catalog number
DYNJ55826A
Device description
TISSUE PROCUREMENT TRAY
Published
2023-12-24
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
FMHCONTAINER, SPECIMEN, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327578634PackageGS13In Commercial Distribution
10195327578633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532757863440195327578634
1019532757863310195327578633

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
false
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
16970462546716Broncho SamplerShenzhen HugeMed Medical Technical Development Co., Ltd.FMH2026-02-10
H1084306553CorningCorning IncorporatedFMH2026-01-26
H1083540143Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540173Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540203Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H108117393CorningCorning IncorporatedFMH2026-01-14
30815112021475Transpec Specimen Radiography DeviceBracco Diagnostics Inc.FMH2026-01-09
30815112021482TranspecBracco Diagnostics Inc.FMH2026-01-09
00810124536923Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyFMH2025-12-05
40198459304638MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-08-18
40198459382964MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-07-02
20816203023913O-Wrap™ BagORIGEN BIOMEDICAL, INC.FMH2025-06-18
20816203024019TissueVault™ Cell & Tissue Freezing BagORIGEN BIOMEDICAL, INC.FMH2025-06-18
20816203024095O-Wrap™ BagORIGEN BIOMEDICAL, INC.FMH2025-06-18
20816203024156TissueVault™ Cell & Tissue Freezing BagORIGEN BIOMEDICAL, INC.FMH2025-06-18
40080196035299MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
40884389226262MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
40888277117922MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
40198459351328MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-06-02
00840165500300Leakbuster 3Starplex Scientific Corp.FMH2025-05-28
00840165500324Leakbuster 3Starplex Scientific Corp.FMH2025-05-28
00840165500362LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500485LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500508LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500058LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500072StarCLICK 100Starplex Scientific Corp.FMH2025-05-28
00840165500294Leakbuster 3Starplex Scientific Corp.FMH2025-05-28
00840165500355LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500393LeakbusterStarplex Scientific Corp.FMH2025-05-28
00840165500454LeakbusterStarplex Scientific Corp.FMH2025-05-28