FDA.reportPublic FDA data

Halyard

Primary DI
10809160540817
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
MWOS97-02
Catalog number
MWOS97-02
Published
2026-10-19
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

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
20809160540814PackageGS13In Commercial Distribution
10809160540817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916054081420809160540814
1080916054081710809160540817

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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160540787HalyardBPVP85-01_0002BPVP85-012026-10-19
10809160540794HalyardTNCA09_0007TNCA092026-10-19
10809160540800HalyardJCLC12F_0009JCLC12F2026-10-19
10809160540824HalyardUSAR034-20_0013USAR034-202026-10-19
10809160540831HalyardEURO055-01_0007EURO055-012026-10-19
10809160540664HalyardDUDV85-02_0001DUDV85-022026-10-16
10809160540671HalyardDAGV13-03_0001DAGV13-032026-10-16
10809160540688HalyardDGAG83-05_0001DGAG83-052026-10-16
10809160540695HalyardDAGL72-02_0001DAGL72-022026-10-16
10809160540701HALYARDBPHD16-02BPHD16-022026-10-16
10809160540718HALYARDBPKB46-02BPKB46-022026-10-16
10809160540725HALYARDBPSF60-02BPSF60-022026-10-16
10809160540732HalyardSPSA58-02SPSA58-022026-10-16
10809160540756HALYARDBPCY61-02BPCY61-022026-10-16
10809160540763HALYARDBPTH37-02BPTH37-022026-10-16
10809160540657HalyardSELF154_0011SELF1542026-10-15
10809160540565HalyardMSBM032-06_0002MSBM032-062026-10-13
10809160540572HalyardSOLC12A-01_0003SOLC12A-012026-10-13
10809160540589HalyardEAMC102-10_0003EAMC102-102026-10-13
10809160540596HalyardDUAD22-01_0008DUAD22-012026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956400795CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956464988CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956506732CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956514874CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956519756CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956533622CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956535459CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956535688CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956548305CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956548695CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956549722CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956549975CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956550780CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956550902CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956551374CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956557741CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956561984CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956565937CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956567894CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956568488CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956571242CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956580084CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956581357CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956582354CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956583955CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956584730CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956584938CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956586314CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956588172CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956591301CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19