FDA.reportPublic FDA data

Halyard

Primary DI
10809160468913
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
WRNM037-16_0001
Catalog number
WRNM037-16
Published
2025-06-02
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
10809160468913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916046891310809160468913

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

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160539002HalyardMAMC223-14_0003MAMC223-142026-09-25
10809160539040HalyardEURO005-09_0005EURO005-092026-09-25
10809160539057HalyardEURO003-10_0005EURO003-102026-09-25
10809160539064HalyardEURO003-11_0002EURO003-112026-09-25
10809160539071HalyardEURO005-10_0002EURO005-102026-09-25
10809160539088HalyardEURO006-10_0002EURO006-102026-09-25
10809160539095HalyardEURO006-09_0001EURO006-092026-09-25
10809160539101HalyardHVBM205-04_0005HVBM205-042026-09-25
10809160539118HalyardWINN117-05_0014WINN117-052026-09-25
10809160538920HALYARDBPEN95-02BPEN95-022026-09-24
10809160538944HalyardMAMC221-16_0031MAMC221-162026-09-24
10809160538951HalyardJACK410-11_0008JACK410-112026-09-24
10809160538975HalyardWBAM044-04_0003WBAM044-042026-09-24
10809160538982HalyardSWMR007-04_0008SWMR007-042026-09-24
10809160538586HalyardGBDV49-02_0011GBDV49-022026-09-22
10809160538593HalyardBPTJ33-02_0019BPTJ33-022026-09-22
10809160538616HalyardHVBM201-06_0005HVBM201-062026-09-22
10809160538623HalyardSAMM018-14_0005SAMM018-142026-09-22
10809160538630HalyardLVMN12-02_0009LVMN12-022026-09-22
10809160538647HalyardWRNM015-12_0006WRNM015-122026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160538944HalyardAVID MEDICAL, INC.OKV2026-09-24
10809160538982HalyardAVID MEDICAL, INC.OKV2026-09-24
10809160538586HalyardAVID MEDICAL, INC.OKV2026-09-22
10809160538623HalyardAVID MEDICAL, INC.OKV2026-09-22
10809160538180HalyardAVID MEDICAL, INC.OKV2026-09-21
10809160538302HalyardAVID MEDICAL, INC.OKV2026-09-21
10809160538463HalyardAVID MEDICAL, INC.OKV2026-09-21
10809160538500HalyardAVID MEDICAL, INC.OKV2026-09-21
10809160537619HalyardAVID MEDICAL, INC.OKV2026-09-19
10809160537800HALYARDAVID MEDICAL, INC.OKV2026-09-19
10809160536568HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160536650HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160537008HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160537022HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160537053HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160532690HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160532805HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160532843HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160532850HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160532881HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160531853HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160531938HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160531969HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160532027HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160532065HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160532096HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160531747HalyardAVID MEDICAL, INC.OKV2026-08-26
10809160531761HalyardAVID MEDICAL, INC.OKV2026-08-26
10809160531327HalyardAVID MEDICAL, INC.OKV2026-08-21
10809160531402HalyardAVID MEDICAL, INC.OKV2026-08-21