FDA.reportPublic FDA data

HALYARD

Primary DI
10809160539194
Brand
HALYARD
Company
AVID MEDICAL, INC.
Model
BPRB41-02
Catalog number
BPRB41-02
Published
2026-09-28
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
20809160539191PackageGS12In Commercial Distribution
10809160539194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053919120809160539191
1080916053919410809160539194

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
10809160539880HalyardHOCY12-01_0006HOCY12-012026-10-06
10809160539897HalyardDVSP33-01_0010DVSP33-012026-10-06
10809160539903HalyardMECS09-01_0008MECS09-012026-10-06
10809160539910HalyardJCHP48-01_0008JCHP48-012026-10-06
10809160539927HalyardMEVG08-01_0002MEVG08-012026-10-06
10809160539934HalyardWENE21-02_0004WENE21-022026-10-06
10809160539941HalyardSOAH30-01_0003SOAH30-012026-10-06
10809160539958HalyardBMHT030-06_0006BMHT030-062026-10-06
10809160539972HalyardDUCG46-01_0009DUCG46-012026-10-06
10809160539989HalyardPSTR001-02_0001PSTR001-022026-10-06
10809160540008HALYARDIHAR39-02IHAR39-022026-10-06
10809160539781HalyardDUUR19-03_0001DUUR19-032026-10-05
10809160539798HalyardRDLD061_0002RDLD0612026-10-05
10809160539804HalyardIHES99_0001IHES992026-10-05
10809160539811HALYARDBPDV50-02BPDV50-022026-10-05
10809160539828HALYARDSTOR11-03STOR11-032026-10-05
10809160539835HALYARDLMLP08-02LMLP08-022026-10-05
10809160539842HalyardDUUR19-03_0002DUUR19-032026-10-05
10809160539859HalyardDUCS29-03_0001DUCS29-032026-10-05
10809160539866HalyardAKNV91-01_0012AKNV91-012026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956439702CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956470163CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
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10198956552098CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956554696CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956556102CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956556690CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956560796CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956562721CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956567399CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956567696CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956568129CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956568747CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06