FDA.reportPublic FDA data

Halyard

Primary DI
10809160528181
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
QCEORSP123_0001
Catalog number
QCEORSP123
Published
2026-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
20809160528188PackageGS12In Commercial Distribution
10809160528181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916052818820809160528188
1080916052818110809160528181

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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.

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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160528112HalyardSAMM041-08_0001SAMM041-082026-07-30
10809160528129HalyardNAMC434-09_0002NAMC434-092026-07-30
10809160528136HalyardNAFB062-09_0001NAFB062-092026-07-30
10809160528143HalyardGBEY17-02_0011GBEY17-022026-07-30
10809160528150HalyardPVHM222-02_0005PVHM222-022026-07-30
10809160528167HalyardSBHT00-06_0001SBHT00-062026-07-30
10809160528174HalyardDONS101-02_0001DONS101-022026-07-30
10809160528198HalyardVMLR032-04_0005VMLR032-042026-07-30
10809160528051HalyardBPTJ33-01_0016BPTJ33-012026-07-29
10809160528075HalyardBMHT301-02_0007BMHT301-022026-07-29
10809160528082HalyardWINN121-11_0004WINN121-112026-07-29
10809160528099HalyardJCSP60F_0011JCSP60F2026-07-29
10809160528105HalyardESEY90-03_0016ESEY90-032026-07-29
10809160527856HalyardAVMD054_0004AVMD0542026-07-28
10809160527863HalyardAVMD052-02_0004AVMD052-022026-07-28
10809160527870HALYARDPVHM201-02PVHM201-022026-07-28
10809160527887HALYARDPVHM205-02PVHM205-022026-07-28
10809160527894HalyardOGDV68-02OGDV68-022026-07-28
10809160527900HalyardUPVD01-02UPVD01-022026-07-28
10809160527924HALYARDPVHM208-02PVHM208-022026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528112HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528136HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528174HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528198HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528051HalyardAVID MEDICAL, INC.LRO2026-07-29
10809160528099HalyardAVID MEDICAL, INC.LRO2026-07-29
10653160393511CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-07-28
10809160527955HALYARDAVID MEDICAL, INC.LRO2026-07-28
10809160527962HALYARDAVID MEDICAL, INC.LRO2026-07-28
10809160527993HalyardAVID MEDICAL, INC.LRO2026-07-28
10809160528044HalyardAVID MEDICAL, INC.LRO2026-07-28
10197106838556CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956355385CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956359512CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956371965CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956384927CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956390102CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956392885CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956393196CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956394735CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956400900CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956401129CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956406544CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956410268CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956423817CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956443136CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956445758CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956445932CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956457829CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956464353CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27