FDA.reportPublic FDA data

Halyard

Primary DI
20809160355623
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
SHAN442-02_0004
Catalog number
SHAN442-02
Published
2021-07-27
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160355623PackageGS13In Commercial Distribution
10809160355626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916035562320809160355623
1080916035562610809160355626

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. 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
HCT/P
false
Kit
true
Combination product
true
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
10809160540428HalyardEURO017-10_0002EURO017-102026-10-09
10809160540435HalyardEAMC103-08_0005EAMC103-082026-10-09
10809160540442HalyardMAMC235-17_0001MAMC235-172026-10-09
10809160540459HalyardMAMC220-12_0002MAMC220-122026-10-09
10809160540466HalyardDNKN06_0012DNKN062026-10-09
10809160540091HalyardSGEP43-03_0005SGEP43-032026-10-08
10809160540114HalyardDNSP11_0008DNSP112026-10-08
10809160540121HalyardDNVP97_0006DNVP972026-10-08
10809160540138HalyardDNPP09_0011DNPP092026-10-08
10809160540145HalyardDNAG08_0011DNAG082026-10-08
10809160540152HalyardDNUR81_0005DNUR812026-10-08
10809160540169HalyardDULP98-03_0001DULP98-032026-10-08
10809160540176HalyardVAST024-08_0013VAST024-082026-10-08
10809160540183HalyardDUPR37-03_0001DUPR37-032026-10-08
10809160540190HalyardDUCR36-03_0001DUCR36-032026-10-08
10809160540206HalyardDULA31-03_0015DULA31-032026-10-08
10809160540213HalyardDUPD23-03_0002DUPD23-032026-10-08
10809160540220HalyardDUPB97-03_0001DUPB97-032026-10-08
10809160540237HalyardDUPN81-02_0008DUPN81-022026-10-08
10809160540244HalyardDULP26-02_0003DULP26-022026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS12158A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-11
B098AMS12324E0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-10
B098AMS12325F0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-10
B098AMS15134C0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-10
B098AMS18228A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-10
10809160540428HalyardAVID MEDICAL, INC.LRO2026-10-09
10809160540435HalyardAVID MEDICAL, INC.LRO2026-10-09
10809160540442HalyardAVID MEDICAL, INC.LRO2026-10-09
10809160540466HalyardAVID MEDICAL, INC.LRO2026-10-09
B098AMS15967C0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-09
B098AMS18164A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-09
B098AMS18454A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-09
B098AMS189410Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-09
B098AMS189420Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-09
B098AMS196710Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-09
B098AMS7496B0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-09
10653160394273MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-08
10653160394709MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-08
10809160540091HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540114HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540138HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540152HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540169HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540206HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540213HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540220HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540237HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540244HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540251HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540275HalyardAVID MEDICAL, INC.LRO2026-10-08