FDA.reportPublic FDA data

Halyard

Primary DI
10809160385289
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
AMCS20AA_0003
Catalog number
AMCS20AA
Published
2022-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
20809160385286PackageGS12In Commercial Distribution
10809160385289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916038528620809160385286
1080916038528910809160385289

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.

Contacts#

Phone, Email table
PhoneEmail
+1(888) 564-7153PIQ@owens-minor.com

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160527719HalyardKOOT801-03_0002KOOT801-032026-07-22
10809160527726HalyardLDSF0001_0004LDSF00012026-07-22
10809160527733HalyardLDSF0002_0002LDSF00022026-07-22
10809160527740HalyardLDSF0003_0002LDSF00032026-07-22
10809160527597HalyardBPTJ33-01_0006BPTJ33-012026-07-21
10809160527603HALYARDPVHM223-02PVHM223-022026-07-21
10809160527610HALYARDPVHM221-02PVHM221-022026-07-21
10809160527627HalyardHVBM208-02_0005HVBM208-022026-07-21
10809160527634HalyardBPMY56-02BPMY56-022026-07-21
10809160527641HalyardNHJV6000-22_0006NHJV6000-222026-07-21
10809160527658HalyardKOOT800-01_0003KOOT800-012026-07-21
10809160527672HalyardSHND401-05_0010SHND401-052026-07-21
10809160527689HalyardMEEP10-01_0008MEEP10-012026-07-21
10809160527696HalyardHVBM222-02_0003HVBM222-022026-07-21
10809160527702HalyardSGGR61-04_0002SGGR61-042026-07-21
10809160527542HalyardUSAR053-16_0001USAR053-162026-07-20
10809160527559HalyardSAMM034-21_0001SAMM034-212026-07-20
10809160527566HalyardWILF003-24_0004WILF003-242026-07-20
10809160527573HalyardAVMD057_0001AVMD0572026-07-20
10809160527580HalyardSAMM066-18_0001SAMM066-182026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160527702HalyardAVID MEDICAL, INC.OKV2026-07-21
10198956532250CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-20
10809160527542HalyardAVID MEDICAL, INC.OKV2026-07-20
10809160527382HalyardAVID MEDICAL, INC.OKV2026-07-17
10809160527498HalyardAVID MEDICAL, INC.OKV2026-07-17
10198956486584CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-16
10809160527269HalyardAVID MEDICAL, INC.OKV2026-07-16
10198956388208CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-09
10809160526927HalyardAVID MEDICAL, INC.OKV2026-07-09
10809160526941HalyardAVID MEDICAL, INC.OKV2026-07-09
10809160526842HalyardAVID MEDICAL, INC.OKV2026-07-08
10809160526811HalyardAVID MEDICAL, INC.OKV2026-07-07
10809160526828HalyardAVID MEDICAL, INC.OKV2026-07-07
10809160526507HalyardAVID MEDICAL, INC.OKV2026-07-06
10809160526309HalyardAVID MEDICAL, INC.OKV2026-06-26
10809160525951HalyardAVID MEDICAL, INC.OKV2026-06-24
10198956485075CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-23
10809160525203HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525258HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525265HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525326HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525500HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525593HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525654HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160523087HalyardAVID MEDICAL, INC.OKV2026-06-09
10809160523117HalyardAVID MEDICAL, INC.OKV2026-06-09
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