FDA.reportPublic FDA data

Halyard

Primary DI
10809160354612
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
WRNM019-11_0003
Catalog number
WRNM019-11
Published
2021-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
10809160354612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916035461210809160354612

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, medicatedA collection of various sterile orthopaedic surgical instruments, dressings, and the necessary materials, which includes a pharmaceutical(s) intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888) 564-7153PIQ@owens-minor.com

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160540657HalyardSELF154_0011SELF1542026-10-15
10809160540565HalyardMSBM032-06_0002MSBM032-062026-10-13
10809160540572HalyardSOLC12A-01_0003SOLC12A-012026-10-13
10809160540589HalyardEAMC102-10_0003EAMC102-102026-10-13
10809160540596HalyardDUAD22-01_0008DUAD22-012026-10-13
10809160540602HalyardMAMC236-19_0003MAMC236-192026-10-13
10809160540497HALYARDBPKN15-02BPKN15-022026-10-12
10809160540510HALYARDBPCL47-02BPCL47-022026-10-12
10809160540527HALYARDBPEX22-02BPEX22-022026-10-12
10809160540534HALYARDBPLA73-02BPLA73-022026-10-12
10809160540541HALYARDBPSA20-02BPSA20-022026-10-12
10809160540558HALYARDGBPM39-02GBPM39-022026-10-12
10809160540428HalyardEURO017-10_0002EURO017-102026-10-09
10809160540435HalyardEAMC103-08_0005EAMC103-082026-10-09
10809160540442HalyardMAMC235-17_0001MAMC235-172026-10-09
10809160540459HalyardMAMC220-12_0002MAMC220-122026-10-09
10809160540466HalyardDNKN06_0012DNKN062026-10-09
10809160540091HalyardSGEP43-03_0005SGEP43-032026-10-08
10809160540114HalyardDNSP11_0008DNSP112026-10-08
10809160540121HalyardDNVP97_0006DNVP972026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956544017CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956549760CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956560765CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956566613CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956569966CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956575868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956587267CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956590533CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956592476CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956598126CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956599550CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956601758CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956604209CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956606623CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10653160394327MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394334MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394488MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394617MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394969MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394983MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395027MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395171MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395188MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395294MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10809160540657HalyardAVID MEDICAL, INC.LRO2026-10-15
10885632540639SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-10-15
10885632540646SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-10-15
10653160395287MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-14
10653160395324MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-14
10653160395416MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-14