FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40198459023805
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ58253B
Catalog number
DYNJ58253B
Device description
GYN PACK
Published
2024-07-29
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
OJFHysterectomy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJFHysterectomy KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40198459023805PackageGS14In Commercial Distribution
10198459023804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845902380540198459023805
1019845902380410198459023804

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
10193489412796Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489413113Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489413953Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489414783Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489424249Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489427813Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489428483Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489430677Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489431650Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489432688Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489448498Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489450422Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489428056Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-04-02
10194717116325Regard™ROI CPS, LLCOJF2022-11-15
10193489950052Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489984231Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489984453Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489986228Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489986846Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489432701Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-06-05
10194717115595Regard™ROI CPS, LLCOJF2022-04-14
10193489950298Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-03-27
10193489952810Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-03-27
10193489987096Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-02-20
10193489950489Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-02-13
10194717114321Regard™ROI CPS, LLCOJF2022-01-13
10193489950335Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2021-11-19
10193489950830Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2021-11-19
10193489952797Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2021-11-19
10193489955224Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2021-11-19