FDA.reportPublic FDA data

Halyard

Primary DI
10809160350737
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
AAFB017-01_0002
Catalog number
AAFB017-01
Published
2021-05-18
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
20809160350734PackageGS12In Commercial Distribution
10809160350737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916035073420809160350734
1080916035073710809160350737

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.

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
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
10809160527047HalyardLMLP08-01_0002LMLP08-012026-07-14
10809160527061HalyardKDAU216-02_0011KDAU216-022026-07-14
10809160527085HalyardDULP19_0005DULP192026-07-14
10809160527092HalyardAKCY76-01_0005AKCY76-012026-07-14
10809160527009HalyardBMHT101-05_0001BMHT101-052026-07-13
10809160527016HalyardBMHT103-05_0001BMHT103-052026-07-13
10809160527023HalyardBMHT102-03_0001BMHT102-032026-07-13
10809160526989HalyardLIFE0223-02_0005LIFE0223-022026-07-10
10809160526996HalyardBMHT110-04_0001BMHT110-042026-07-10
10809160526903HalyardBTMF007-06_0001BTMF007-062026-07-09
10809160526910HalyardDGBB41-02_0004DGBB41-022026-07-09
10809160526927HalyardBMHT200-03_0004BMHT200-032026-07-09
10809160526934HalyardSGCB56-03_0006SGCB56-032026-07-09
10809160526941HalyardSFSSHND415-02_0001SFSSHND415-022026-07-09
10809160526958HalyardLAKC010-08_0004LAKC010-082026-07-09
10809160526965HalyardSFSAKAH37-04_0001SFSAKAH37-042026-07-09
10809160526842HalyardAKCS54-03_0001AKCS54-032026-07-08
10809160526859HalyardDUAG11-01_0007DUAG11-012026-07-08
10809160526880HalyardSELF108-04_0005SELF108-042026-07-08
10809160526897HalyardHVSP206-05_0007HVSP206-052026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160527047HalyardAVID MEDICAL, INC.LRO2026-07-14
10809160527061HalyardAVID MEDICAL, INC.LRO2026-07-14
10809160527085HalyardAVID MEDICAL, INC.LRO2026-07-14
10809160527092HalyardAVID MEDICAL, INC.LRO2026-07-14
10809160527016HalyardAVID MEDICAL, INC.LRO2026-07-13
10809160527023HalyardAVID MEDICAL, INC.LRO2026-07-13
B098AMS14885C0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS17983A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS18306A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS192890Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS192920Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS8144C0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
10809160526989HalyardAVID MEDICAL, INC.LRO2026-07-10
10809160526996HalyardAVID MEDICAL, INC.LRO2026-07-10
10885632524950SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-07-10
10885632526978SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-07-10
10885632526992SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-07-10
10198956074668CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956119260CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956286719CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956386303CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956387959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956420076CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956425996CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956457119CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956459878CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956462007CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956462151CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956473478CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956475427CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09