FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40193489855389
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ45430D
Catalog number
DYNJ45430D
Device description
GENERAL GYN PACK
Published
2021-11-15
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
OHDGynecological laparoscopic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489855389PackageGS16In Commercial Distribution
10193489855388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348985538940193489855389
1019348985538810193489855388

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. 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
true
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
10193489212686Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489212914Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489216318Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489217025Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489413335Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489413854Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489413960Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489419078Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489424027Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489424348Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489425017Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489425536Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489425611Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489428353Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489429619Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489430608Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489438529Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489441369Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489443080Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489443868Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489444537Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489444841Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489444872Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489448719Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489454864Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489455380Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489456165Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489456745Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489457346Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489457391Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08