FDA.reportPublic FDA data

HALYARD

Primary DI
10809160539378
Brand
HALYARD
Company
AVID MEDICAL, INC.
Model
SPTK51-03
Catalog number
SPTK51-03
Published
2026-09-29
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
20809160539375PackageGS12In Commercial Distribution
10809160539378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053937520809160539375
1080916053937810809160539378

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
10809160539507HalyardAVMD020-01_0011AVMD020-012026-10-01
10809160539514HalyardDONS102-02_0001DONS102-022026-10-01
10809160539521HalyardRDLD003-15_0002RDLD003-152026-10-01
10809160539538HalyardSAMT109-11_0003SAMT109-112026-10-01
10809160539545HalyardSHAN430-07_0007SHAN430-072026-10-01
10809160539552HalyardMSMC114-07_0011MSMC114-072026-10-01
10809160539569HalyardDUPR37-02_0002DUPR37-022026-10-01
10809160539385HalyardGBTK48-02_0002GBTK48-022026-09-30
10809160539392HALYARDGBCC47-02GBCC47-022026-09-30
10809160539408HalyardDUEC64-04_0003DUEC64-042026-09-30
10809160539415HalyardHVBM218-03_0003HVBM218-032026-09-30
10809160539422HalyardSOLC12A-01_0001SOLC12A-012026-09-30
10809160539439HalyardHVSP200-05_0003HVSP200-052026-09-30
10809160539446HalyardHVSP212-04_0006HVSP212-042026-09-30
10809160539453HalyardGUGE09-02_0001GUGE09-022026-09-30
10809160539460HalyardMSMC121-03_0001MSMC121-032026-09-30
10809160539477HalyardSTJO002-08_0004STJO002-082026-09-30
10809160539484HalyardMSBM042-08_0006MSBM042-082026-09-30
10809160539491HalyardJACK400-06_0005JACK400-062026-09-30
10809160539217HalyardMMBN007-02_0016MMBN007-022026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956333901CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956530645CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956537262CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956539563CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956542631CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956558915CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956559608CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956560147CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956562592CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956562967CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956563018CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956566880CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956567429CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956567467CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956567771CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956568976CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956569256CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956570894CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956570900CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956571549CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956580091CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956582941CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956587373CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956592353CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956592735CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956592865CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956593695CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956596443CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956356122CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-29
10198956474888CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-29