FDA.reportPublic FDA data

HALYARD

Primary DI
10809160540497
Brand
HALYARD
Company
AVID MEDICAL, INC.
Model
BPKN15-02
Catalog number
BPKN15-02
Published
2026-10-12
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

Product Codes#

Code, Name table
CodeName
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160540494PackageGS12In Commercial Distribution
10809160540497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916054049420809160540494
1080916054049710809160540497

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10809160540138HalyardDNPP09_0011DNPP092026-10-08
10809160540145HalyardDNAG08_0011DNAG082026-10-08
10809160540152HalyardDNUR81_0005DNUR812026-10-08
10809160540169HalyardDULP98-03_0001DULP98-032026-10-08
10809160540176HalyardVAST024-08_0013VAST024-082026-10-08
10809160540183HalyardDUPR37-03_0001DUPR37-032026-10-08
10809160540190HalyardDUCR36-03_0001DUCR36-032026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956276437CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
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10198956333611CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956361041CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956384439CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956388376CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956519541CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956530782CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956540958CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956544086CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956550063CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956552104CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956552531CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956556478CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956556591CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956557079CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956564145CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956567405CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956567672CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956567931CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956569294CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956570061CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956570078CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956573567CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956574571CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956575585CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956577275CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956578197CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956580367CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956581142CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12