FDA.reportPublic FDA data

Halyard

Primary DI
20809160469993
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
IHER22-01
Published
2025-06-12
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
OGREar, nose, and throat surgical tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGREar, Nose, And Throat Surgical TrayEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160469993PackageGS127In Commercial Distribution
10809160469996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916046999320809160469993
1080916046999610809160469996

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

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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160523063HalyardSFSLVTJ65-01_0001SFSLVTJ65-012026-06-09
10809160523070HalyardLVTJ65-01_0011LVTJ65-012026-06-09
10809160523087HalyardSFSMSBM022-06_0003SFSMSBM022-062026-06-09
10809160523094HalyardAXOG2000-11_0001AXOG2000-112026-06-09
10809160523100HalyardACTK56-03_0009ACTK56-032026-06-09
10809160523117HalyardSGGY67-05_0003SGGY67-052026-06-09
10809160523124HalyardBMHT020-05_0001BMHT020-052026-06-09
10809160523131HalyardSHAN409-06_0004SHAN409-062026-06-09
10809160523148HalyardAMCH001-02_0002AMCH001-022026-06-09
10809160523162HalyardDUCD44-03_0003DUCD44-032026-06-09
10809160523179HalyardLLHT24-01_0006LLHT24-012026-06-09
10809160523186HalyardLMCV54-01_0002LMCV54-012026-06-09
10809160523193HalyardUICD62-01_0004UICD62-012026-06-09
10809160523209HalyardRCOH61-01_0007RCOH61-012026-06-09
10809160523216HalyardUICS88-01_0002UICS88-012026-06-09
10809160523223HalyardUIPD03-01_0005UIPD03-012026-06-09
10809160523230HalyardWILF002-23_0005WILF002-232026-06-09
10809160523247HalyardWILF002-23_0006WILF002-232026-06-09
10809160522820HalyardSFSJACK455-05_0002SFSJACK455-052026-06-08
10809160522837HalyardSFSBMHU003-05_0001SFSBMHU003-052026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106983577CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956362932CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956386150CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956390430CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956402683CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956489424CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956495203CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956501676CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956503809CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956385795CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956423930CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956439269CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956444379CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956466272CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956472907CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956473201CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956487024CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956492004CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956492585CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956492790CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956498587CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956498792CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956500563CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
B098AMS177290Aligned Medical SolutionsAligned Medical SolutionsOGR2026-06-05
10198956443570CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956479609CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956490857CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956492653CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956494237CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956497009CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03