FDA.report

Halyard

Primary DI
20809160472016
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
SFLM54-01
Catalog number
SFLM54-01
Published
2025-07-02
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

Product Codes

CodeName
OJGNeurological tray

Product Code Classifications

CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160472016PackageGS13In Commercial Distribution
10809160472019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916047201620809160472016
1080916047201910809160472019

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Sterilization Methods

Method

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 DIBrandModelCatalogPublished
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
50198956335569CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-24
50198956359046CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-24
50198956425833CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-24
50198956427448CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-24
50197106906055CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50197106926794CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956221060CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956292541CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956311020CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956313123CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956322132CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956323429CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956323665CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956324198CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956327106CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956329278CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956334463CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956334746CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956335842CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956340259CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956341423CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956349382CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956357400CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956358070CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956361407CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956362114CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956362688CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956365214CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956365511CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956368697CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23