FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40193489447089
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ68450
Catalog number
DYNJ68450
Device description
PERI GYN PACK NTX
Published
2021-08-30
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
OKVObstetrical kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKVObstetrical KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489447089PackageGS12In Commercial Distribution
10193489447088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348944708940193489447089
1019348944708810193489447088

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
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