FDA.reportPublic FDA data

Medline

Primary DI
10080196915118
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJP6020A
Catalog number
DYNJP6020A
Device description
DBD-PACK,OB III,AURORA
Published
2021-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10080196915118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1008019691511810080196915118

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
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
10809160521830HalyardAVID MEDICAL, INC.LRO2026-05-26
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10198956380127CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956383647CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956387287CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956388406CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956413757CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956416802CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956426146CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956427242CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956430174CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956437265CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956441910CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956444478CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956444775CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956445680CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956453753CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956455528CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956456624CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956457096CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956457713CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956457959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956460638CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956461741CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956462014CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956463516CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956464360CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956465831CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956465855CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25