FDA.reportPublic FDA data

Halyard

Primary DI
10809160310748
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
GVVA004-06_0004
Catalog number
GVVA004-06
Published
2020-12-10
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
OJKEye tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10809160310748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916031074810809160310748

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical procedure kit, medicated, single-useA collection of various sterile ophthalmic surgical instruments, dressings, and the necessary materials which includes a pharmaceutical(s) intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedure (e.g., device implantation). 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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160526156HALYARDPVHM204-02PVHM204-022026-07-06
10809160526484HalyardLANC009-34_0008LANC009-342026-07-06
10809160526491HalyardSGMN13-04_0011SGMN13-042026-07-06
10809160526507HalyardAVMD054_0002AVMD0542026-07-06
10809160526514HalyardSHAN446-04_0002SHAN446-042026-07-06
10809160526521HalyardONEL1180-04_0005ONEL1180-042026-07-06
10809160526545HalyardGBTJ22-02_0017GBTJ22-022026-07-06
10809160526798HalyardLIFE0242-02_0008LIFE0242-022026-07-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956525733CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525801CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525900CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525917CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525931CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525955CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956526051CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956526532CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956527485CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
B098AMS193380Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-05
10198956227552CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956418899CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956475380CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956475441CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956475489CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956477551CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956489264CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956498556CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956501911CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956470507CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956490260CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956491960CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956492776CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956493001CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956493377CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956495173CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956496569CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956499744CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956397682CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10198956417229CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03