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
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
B098AMS199160Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS199340Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS199930Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS6160F0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS9487F0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS9509E0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
10198956374232CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956400801CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956424654CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956486645CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956500730CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956512016CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956519275CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956524033CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956541504CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956541603CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956545151CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956545168CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956548299CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956550575CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956551022CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956551091CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956556492CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956556638CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956557567CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956558960CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956559646CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956560079CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956560598CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956561212CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25