FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327472246
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ906514D
Catalog number
DYNJ906514D
Device description
D&C / GYN
Published
2023-08-06
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
OKVObstetrical kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKVObstetrical KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327472246PackageGS12In Commercial Distribution
10195327472245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532747224640195327472246
1019532747224510195327472245

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
10198956441880CARDINAL HEALTHCardinal Health 200, LLCOKV2026-05-25
10198956482388CARDINAL HEALTHCardinal Health 200, LLCOKV2026-05-25
50198956426854CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-24
50198956358407CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-23
50198956396638CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-23
50198956424461CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-23
50198956424720CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-23
50198956425482CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-23
20809160517168HalyardAVID MEDICAL, INC.OKV2026-03-23
20809160517199HalyardAVID MEDICAL, INC.OKV2026-03-23
20809160516758HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516765HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516772HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516826HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516963HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516970HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160517021HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160517083HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516697HalyardAVID MEDICAL, INC.OKV2026-03-19
20809160516703HalyardAVID MEDICAL, INC.OKV2026-03-19
50198956329889CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-16
20809160516222HalyardAVID MEDICAL, INC.OKV2026-03-16
20809160516260HalyardAVID MEDICAL, INC.OKV2026-03-16
20809160516277HalyardAVID MEDICAL, INC.OKV2026-03-16
20809160515966HalyardAVID MEDICAL, INC.OKV2026-03-12
50198956363043CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-10
50198956393316CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-10
50198956411010CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-10
50198956405910CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-09
20809160515270HalyardAVID MEDICAL, INC.OKV2026-03-09