FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40198459179373
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ19833D
Catalog number
DYNJ19833D
Device description
ST MARY'S STL C-SECTION -LF #2
Published
2024-11-17
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
OHMCesarean section tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHMCesarean Section TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40198459179373PackageGS12In Commercial Distribution
10198459179372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845917937340198459179373
1019845917937210198459179372

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
10080196943470Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2025-02-16
10080196887545Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-07-29
10193489441772Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-13
10193489212624Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489417081Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489418163Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489418989Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489419108Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489420524Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489420739Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489420876Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489423112Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489423181Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489424423Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489425598Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489426267Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489426434Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489428711Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489429534Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489430264Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489431070Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489432183Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489443455Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489443745Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489446142Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489450972Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489454673Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489455304Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489455618Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489456905Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08