FDA.report

Halyard

Primary DI
20809160432096
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
SHER800-01_0002
Catalog number
SHER800-01
Published
2024-08-14
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
20809160432096PackageGS112In Commercial Distribution
10809160432099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916043209620809160432096
1080916043209910809160432099

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

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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
20809160517229HalyardESED52-01_0013ESED52-012026-03-23
20809160516734HalyardLIFE0156-03_0008LIFE0156-032026-03-20
20809160516741HalyardWERP43-01_0002WERP43-012026-03-20
20809160516758HalyardWEGL20-01_0004WEGL20-012026-03-20
20809160516765HalyardWEHY18-01_0002WEHY18-012026-03-20
20809160516772HalyardWEGB22-01_0002WEGB22-012026-03-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956219043CARDINAL 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
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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
50198956428926CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
20809160517243HalyardAVID MEDICAL, INC.LRO2026-03-24
20809160517250HalyardAVID MEDICAL, INC.LRO2026-03-24
50198956157550CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-23
50198956220742CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-23
50198956273168CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-23