FDA.reportPublic FDA data

Halyard

Primary DI
20809160512996
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
FTDH99-03_0007
Catalog number
FTDH99-03
Published
2026-02-18
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
OKVObstetrical kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKVObstetrical KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160512996PackageGS12In Commercial Distribution
10809160512999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916051299620809160512996
1080916051299910809160512999

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160522820HalyardSFSJACK455-05_0002SFSJACK455-052026-06-08
10809160522837HalyardSFSBMHU003-05_0001SFSBMHU003-052026-06-08
10809160522844HalyardSFSJACK435-09_0001SFSJACK435-092026-06-08
10809160522851HalyardBMHU003-05_0001BMHU003-052026-06-08
10809160522868HalyardSFSMSBM022-06_0001SFSMSBM022-062026-06-08
10809160522875HalyardMSBM030-06_0007MSBM030-062026-06-08
10809160522882HalyardMSBM022-06_0006MSBM022-062026-06-08
10809160522899HalyardJACK435-09_0005JACK435-092026-06-08
10809160522905HalyardSFSMSBM030-06_0002SFSMSBM030-062026-06-08
10809160522912HalyardJACK455-05_0001JACK455-052026-06-08
10809160522929HalyardSFSJCLC12-01_0001SFSJCLC12-012026-06-08
10809160522936HalyardSHAN453-04_0015SHAN453-042026-06-08
10809160522943HalyardBMHT030-05_0003BMHT030-052026-06-08
10809160522950HalyardMAMC229-22_0001MAMC229-222026-06-08
10809160522967HalyardACTK56-03_0008ACTK56-032026-06-08
10809160522974HalyardDGAL24-03_0007DGAL24-032026-06-08
10809160522981HalyardAVMD016-02_0005AVMD016-022026-06-08
10809160522998HalyardMEHY02O_0011MEHY02O2026-06-08
10809160523001HalyardMCBP83-02_0005MCBP83-022026-06-08
10809160523018HalyardMAMC213-09_0004MAMC213-092026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956454101CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-08
10809160522837HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522851HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522868HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522882HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522974HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522998HalyardAVID MEDICAL, INC.OKV2026-06-08
10198956445000CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-05
10809160522776HalyardAVID MEDICAL, INC.OKV2026-06-05
10809160522424HalyardAVID MEDICAL, INC.OKV2026-06-02
10809160522431HalyardAVID MEDICAL, INC.OKV2026-06-02
10198956488229CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-01
10809160522165HalyardAVID MEDICAL, INC.OKV2026-06-01
10809160522257HalyardAVID MEDICAL, INC.OKV2026-06-01
10809160522141HalyardAVID MEDICAL, INC.OKV2026-05-29
10809160521915HalyardAVID MEDICAL, INC.OKV2026-05-27
10193489991543Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-10-15
10193489214284Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489215823Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489410211Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489412475Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413014Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413809Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413984Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489419931Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489421637Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489424218Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489425758Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489426694Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489427516Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08