FDA.reportPublic FDA data

Halyard

Primary DI
10809160484098
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
UIEB48-01
Catalog number
UIEB48-01
Published
2025-07-09
Public version status
Update
Distribution status
Not 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
20809160484095PackageGS160Not in Commercial Distribution
10809160484098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916048409520809160484095
1080916048409810809160484098

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
false
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
10809160522660HalyardDGAD64-01_0007DGAD64-012026-06-05
10809160522677HalyardVMCL027-13_0002VMCL027-132026-06-05
10809160522684HalyardLLTV10-01_0003LLTV10-012026-06-05
10809160522691HalyardHVSP211-03_0003HVSP211-032026-06-05
10809160522707HalyardBJAC006-29_0008BJAC006-292026-06-05
10809160522714HalyardAXOGSUB3-11_0002AXOGSUB3-112026-06-05
10809160522721HalyardBMHU005-05_0001BMHU005-052026-06-05
10809160522738HalyardGVVA002-08_0008GVVA002-082026-06-05
10809160522745HalyardHOTH40D_0008HOTH40D2026-06-05
10809160522752HalyardDUTT20_0005DUTT202026-06-05
10809160522769HalyardFBCH126-02_0005FBCH126-022026-06-05
10809160522776HalyardBMHU003-04_0004BMHU003-042026-06-05
10809160522783HalyardACTK56-03_0007ACTK56-032026-06-05
10809160469972HalyardAMTS70-012025-06-12
10809160479148HalyardLMDP36-01LMDP36-012025-07-09
10809160522554HalyardAVMD011-03_0006AVMD011-032026-06-04
10809160522561HalyardJACK410-11_0005JACK410-112026-06-04
10809160522578HalyardDGNE75-02_0011DGNE75-022026-06-04
10809160522585HalyardLCNW004-01_0001LCNW004-012026-06-04
10809160522592HalyardBTMF009-08_0002BTMF009-082026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956286665CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956305274CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956345928CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956359963CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956364905CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956382657CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956393141CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956395275CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956404144CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956404656CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956415171CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956422971CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956430716CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956439481CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956440814CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956446038CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956446045CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956452930CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956453173CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956454453CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956454866CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956458710CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956463912CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956465633CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956471856CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956472792CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956473140CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956475250CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956476004CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956476257CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05