FDA.reportPublic FDA data

HALYARD

Primary DI
10809160539392
Brand
HALYARD
Company
AVID MEDICAL, INC.
Model
GBCC47-02
Catalog number
GBCC47-02
Published
2026-09-30
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
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160539399PackageGS14In Commercial Distribution
10809160539392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053939920809160539399
1080916053939210809160539392

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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
true
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
10809160539507HalyardAVMD020-01_0011AVMD020-012026-10-01
10809160539514HalyardDONS102-02_0001DONS102-022026-10-01
10809160539521HalyardRDLD003-15_0002RDLD003-152026-10-01
10809160539538HalyardSAMT109-11_0003SAMT109-112026-10-01
10809160539545HalyardSHAN430-07_0007SHAN430-072026-10-01
10809160539552HalyardMSMC114-07_0011MSMC114-072026-10-01
10809160539569HalyardDUPR37-02_0002DUPR37-022026-10-01
10809160539385HalyardGBTK48-02_0002GBTK48-022026-09-30
10809160539408HalyardDUEC64-04_0003DUEC64-042026-09-30
10809160539415HalyardHVBM218-03_0003HVBM218-032026-09-30
10809160539422HalyardSOLC12A-01_0001SOLC12A-012026-09-30
10809160539439HalyardHVSP200-05_0003HVSP200-052026-09-30
10809160539446HalyardHVSP212-04_0006HVSP212-042026-09-30
10809160539453HalyardGUGE09-02_0001GUGE09-022026-09-30
10809160539460HalyardMSMC121-03_0001MSMC121-032026-09-30
10809160539477HalyardSTJO002-08_0004STJO002-082026-09-30
10809160539484HalyardMSBM042-08_0006MSBM042-082026-09-30
10809160539491HalyardJACK400-06_0005JACK400-062026-09-30
10809160539217HalyardMMBN007-02_0016MMBN007-022026-09-29
10809160539224HalyardSLCN72-05_0003SLCN72-052026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956587298CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-01
10809160539569HalyardAVID MEDICAL, INC.OEZ2026-10-01
10197106980361CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956485105CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956563247CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956565913CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956568167CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956575745CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956578999CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956589209CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956590083CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592285CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592599CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592636CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592704CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592810CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956593688CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956593961CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956594623CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956595255CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956596078CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956596153CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956598225CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10809160539408HalyardAVID MEDICAL, INC.OEZ2026-09-30
10809160539460HalyardAVID MEDICAL, INC.OEZ2026-09-30
10809160539484HalyardAVID MEDICAL, INC.OEZ2026-09-30
00884450421383Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-29
00884450431917Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-29
00884450500002Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-29
10198956474925CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-29