FDA.reportPublic FDA data

Halyard

Primary DI
10809160531839
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
BPLP28-02
Catalog number
BPLP28-02
Published
2026-08-26
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
OJKEye tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160531836PackageGS118In Commercial Distribution
10809160531839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053183620809160531836
1080916053183910809160531839

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

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
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
10198956538795CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956565326CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956571136CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956581821CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956581845CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956588950CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956590380CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25
10198956547575CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956554092CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956562899CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956567306CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956571440CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956571709CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956584914CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956587595CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956588790CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956589162CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-22
10198956373198CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-21
10198956481961CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-21
10198956577008CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-21
10198956580879CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-21
10198956580886CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-21
10198956583948CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-21
10809160538159HalyardAVID MEDICAL, INC.OJK2026-09-21
10809160538166HalyardAVID MEDICAL, INC.OJK2026-09-21
10809160538203HalyardAVID MEDICAL, INC.OJK2026-09-21
10809160538524HalyardAVID MEDICAL, INC.OJK2026-09-21
10809160538012HalyardAVID MEDICAL, INC.OJK2026-09-20
10809160537657HalyardAVID MEDICAL, INC.OJK2026-09-19
10809160537718HalyardAVID MEDICAL, INC.OJK2026-09-19