FDA.report

Halyard

Primary DI
20809160457945
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
BMHT011-03_0006
Catalog number
BMHT011-03
Published
2025-02-20
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

Related Records

Contact Domains

Product Codes

CodeName
LROGeneral surgery tray

Product Code Classifications

CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160457945PackageGS13In Commercial Distribution
10809160457948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916045794520809160457945
1080916045794810809160457948

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888) 564-7153PIQ@owens-minor.com

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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10809160521731HalyardWINN122-09_0004WINN122-092026-05-22
10809160521762HalyardUSAR061-08_0004USAR061-082026-05-22
10809160521779HalyardWINN112-06_0014WINN112-062026-05-22
10809160521786HalyardUIPP85-02UIPP85-022026-05-22
10809160521793HalyardWINN112-06_0002WINN112-062026-05-22
10809160521809HalyardESFS76-01_0007ESFS76-012026-05-22
20809160517236HalyardDRRD48-02_0004DRRD48-022026-03-24
20809160517243HalyardAVMD050-01_0007AVMD050-012026-03-24
20809160517250HalyardUSAR017-12_0006USAR017-122026-03-24
20809160517090HalyardLIFE0240_0006LIFE02402026-03-23
20809160517120HalyardKAFB027_0010KAFB0272026-03-23
20809160517137HalyardUFCF010-03_0008UFCF010-032026-03-23
20809160517144HalyardVMCD018-11_0004VMCD018-112026-03-23
20809160517151HalyardVAML019-09_0004VAML019-092026-03-23
20809160517168HalyardNHJV7000-20_0008NHJV7000-202026-03-23
20809160517175HalyardEAMC109-06_0008EAMC109-062026-03-23
20809160517182HalyardOSTK19-01_0007OSTK19-012026-03-23
20809160517199HalyardDUAC16-01_0010DUAC16-012026-03-23
20809160517205HalyardVAML058_0017VAML0582026-03-23
20809160517212HalyardSAMT100-12_0007SAMT100-122026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10809160521748MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.LRO2026-05-22
10809160521762HalyardAVID MEDICAL, INC.LRO2026-05-22
10809160521779HalyardAVID MEDICAL, INC.LRO2026-05-22
10809160521793HalyardAVID MEDICAL, INC.LRO2026-05-22
10809160521809HalyardAVID MEDICAL, INC.LRO2026-05-22
10885632521751SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-05-22
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50198956300116CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
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50198956327939CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956334760CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956359893CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
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50198956379211CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956382150CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956391329CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956391541CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956392616CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956392890CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956394542CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956399073CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956414585CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956414806CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956415230CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956415926CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956416862CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956419788CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956425376CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956427493CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956427677CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24