FDA.reportPublic FDA data

Halyard

Primary DI
10809160475911
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
GNMJ01-01
Catalog number
GNMJ01-01
Published
2025-07-09
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

Product Codes#

Code, Name table
CodeName
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160475918PackageGS13In Commercial Distribution
10809160475911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916047591820809160475918
1080916047591110809160475911

GMDN Terms#

Term, Definition table
TermDefinition
External facial prosthesisAn externally-applied device intended to be used as an artificial substitute for two or more sections of the face [typically eye(s) and/or nose and surrounding regions (e.g., eye brows, forehead, midface)] to help restore facial appearance. The device is customized to meet the patient's needs and may be held in position with magnets or screw-like implants embedded into the patient's facial bone. It is used in cases of severe facial disfigurement typically caused by trauma (e.g., gunshot wounds) or major facial cancer surgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160527177HALYARDPVHM213-03PVHM213-032026-07-17
10809160527313HalyardDHOR82-01_0002DHOR82-012026-07-17
10809160527320HalyardWBAM032-12_0001WBAM032-122026-07-17
10809160527337HalyardPVHM225-01PVHM225-012026-07-17
10809160527344HalyardVAPX018-10_0010VAPX018-102026-07-17
10809160527351HalyardBMHT029-02_0002BMHT029-022026-07-17
10809160527368HalyardBMHT031-06_0005BMHT031-062026-07-17
10809160527375HalyardARMC015_0013ARMC0152026-07-17
10809160527382HalyardBMGT003-03_0005BMGT003-032026-07-17
10809160527399HalyardBMGT016-05_0002BMGT016-052026-07-17
10809160527405HalyardBMGT014-04_0003BMGT014-042026-07-17
10809160527412HalyardBMHT031-06_0006BMHT031-062026-07-17
10809160527429HalyardBMHT107-06_0006BMHT107-062026-07-17
10809160527436HalyardMSBM004-06_0008MSBM004-062026-07-17
10809160527443HalyardMSBM006-02_0011MSBM006-022026-07-17
10809160527450HalyardMSBM027-05_0004MSBM027-052026-07-17
10809160527467HalyardBMHT400-02_0011BMHT400-022026-07-17
10809160527474HalyardBMHT401-03_0004BMHT401-032026-07-17
10809160527481HalyardDUPD23-02_0006DUPD23-022026-07-17
10809160527498HalyardWBAM054-02ANC_0003WBAM054-02ANC2026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956232792CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956334342CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956359611CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956364837CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956368002CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956392755CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956408401CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956439726CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956442450CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956448308CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956448483CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956458291CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956461512CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956475328CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956481367CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956484269CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956487314CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956489875CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956504424CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956504776CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956504806CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956505490CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956505704CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956506909CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956507685CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956508019CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956508170CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956509382CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956509603CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956510418CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16