FDA.reportPublic FDA data

HALYARD

Primary DI
10809160538739
Brand
HALYARD
Company
AVID MEDICAL, INC.
Model
BPSA44-02
Catalog number
BPSA44-02
Published
2026-09-22
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
20809160538736PackageGS16In Commercial Distribution
10809160538739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053873620809160538736
1080916053873910809160538739

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
false
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
10809160538920HALYARDBPEN95-02BPEN95-022026-09-24
10809160538944HalyardMAMC221-16_0031MAMC221-162026-09-24
10809160538951HalyardJACK410-11_0008JACK410-112026-09-24
10809160538975HalyardWBAM044-04_0003WBAM044-042026-09-24
10809160538982HalyardSWMR007-04_0008SWMR007-042026-09-24
10809160538586HalyardGBDV49-02_0011GBDV49-022026-09-22
10809160538593HalyardBPTJ33-02_0019BPTJ33-022026-09-22
10809160538616HalyardHVBM201-06_0005HVBM201-062026-09-22
10809160538623HalyardSAMM018-14_0005SAMM018-142026-09-22
10809160538630HalyardLVMN12-02_0009LVMN12-022026-09-22
10809160538647HalyardWRNM015-12_0006WRNM015-122026-09-22
10809160538654HalyardWRNM024-17_0003WRNM024-172026-09-22
10809160538661HalyardLVMJ21-03_0014LVMJ21-032026-09-22
10809160538678HalyardWRNM026-18_0008WRNM026-182026-09-22
10809160538685HalyardLVRB53-01_0011LVRB53-012026-09-22
10809160538692HalyardLVHD29-03_0011LVHD29-032026-09-22
10809160538708HalyardEURO051-03_0003EURO051-032026-09-22
10809160538715HalyardWRNM085-03_0004WRNM085-032026-09-22
10809160538722HalyardBAAK100-12_0010BAAK100-122026-09-22
10809160538050HalyardVAMH009-06_0002VAMH009-062026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556839690Total Foot System 2Smith & Nephew, Inc.OJH2026-09-24
00885556839706Total Foot System 2Smith & Nephew, Inc.OJH2026-09-24
00885556859636Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859643Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859650Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859698Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859704Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859711Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859728Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859735Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859742Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859759Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859766Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859773Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859780Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859797Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859803Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
10198956362550CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956415607CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956462984CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956502468CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956507654CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956513365CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956520257CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956533264CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956538214CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956545618CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956545687CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956552005CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956552203CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22