FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40198459145811
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ905317K
Catalog number
DYNJ905317K
Device description
LAPAROSCOPIC
Published
2024-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDElaparoscopy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDELaparoscopy KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40198459145811PackageGS13In Commercial Distribution
10198459145810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845914581140198459145811
1019845914581010198459145810

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
10080196887248Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2025-01-19
10080196926213Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2025-01-19
10193489213928Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2024-07-29
10080196498192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-07-29
10080196498345Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-07-29
10193489211658Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489212594Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489213003Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489213515Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489214116Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489214154Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489215472Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489216769Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489287592Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489288285Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489288407Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489288414Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489289732Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489289749Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489289848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489290059Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489290189Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489290196Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489290240Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489291049Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489291100Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489291155Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489291902Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489292114Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489292121Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09