FDA.reportPublic FDA data

HALYARD

Primary DI
10809160539828
Brand
HALYARD
Company
AVID MEDICAL, INC.
Model
STOR11-03
Catalog number
STOR11-03
Published
2026-10-05
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
20809160539825PackageGS13In Commercial Distribution
10809160539828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053982520809160539825
1080916053982810809160539828

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
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
10809160539835HALYARDLMLP08-02LMLP08-022026-10-05
10809160539842HalyardDUUR19-03_0002DUUR19-032026-10-05
10809160539859HalyardDUCS29-03_0001DUCS29-032026-10-05
10809160539866HalyardAKNV91-01_0012AKNV91-012026-10-05
10809160539873HalyardRDLD014-07_0002RDLD014-072026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956286672CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956301511CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956306059CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956354494CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956379824CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956402416CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956439702CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956470163CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956512146CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956514522CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956519985CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956523555CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956532083CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956543089CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956543942CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956545359CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956548855CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956548916CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956548961CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956552012CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
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