FDA.reportPublic FDA data

Halyard

Primary DI
10809160527634
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
BPMY56-02
Catalog number
BPMY56-02
Published
2026-07-21
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
OGSMyringotomy procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGSMyringotomy Procedure KitEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160527631PackageGS120In Commercial Distribution
10809160527634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916052763120809160527631
1080916052763410809160527634

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
10809160527719HalyardKOOT801-03_0002KOOT801-032026-07-22
10809160527726HalyardLDSF0001_0004LDSF00012026-07-22
10809160527733HalyardLDSF0002_0002LDSF00022026-07-22
10809160527740HalyardLDSF0003_0002LDSF00032026-07-22
10809160527597HalyardBPTJ33-01_0006BPTJ33-012026-07-21
10809160527603HALYARDPVHM223-02PVHM223-022026-07-21
10809160527610HALYARDPVHM221-02PVHM221-022026-07-21
10809160527627HalyardHVBM208-02_0005HVBM208-022026-07-21
10809160527641HalyardNHJV6000-22_0006NHJV6000-222026-07-21
10809160527658HalyardKOOT800-01_0003KOOT800-012026-07-21
10809160527672HalyardSHND401-05_0010SHND401-052026-07-21
10809160527689HalyardMEEP10-01_0008MEEP10-012026-07-21
10809160527696HalyardHVBM222-02_0003HVBM222-022026-07-21
10809160527702HalyardSGGR61-04_0002SGGR61-042026-07-21
10809160527542HalyardUSAR053-16_0001USAR053-162026-07-20
10809160527559HalyardSAMM034-21_0001SAMM034-212026-07-20
10809160527566HalyardWILF003-24_0004WILF003-242026-07-20
10809160527573HalyardAVMD057_0001AVMD0572026-07-20
10809160527580HalyardSAMM066-18_0001SAMM066-182026-07-20
10809160527177HALYARDPVHM213-03PVHM213-032026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956374195CARDINAL HEALTHCardinal Health 200, LLCOGS2026-04-14
10198956403369CARDINAL HEALTHCardinal Health 200, LLCOGS2026-03-19
50198956403367CARDINAL HEALTHCardinal Health 200, LLCOGS2026-03-19
10198956358874CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
10198956369054CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
50198956358872CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
50198956369052CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
10198956317628CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-13
50198956317626CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-13
00191072241351ACSAMERICAN CONTRACT SYSTEMS, INC.OGS2026-01-06
10198956261679CARDINAL HEALTHCardinal Health 200, LLCOGS2025-12-17
50198956261677CARDINAL HEALTHCardinal Health 200, LLCOGS2025-12-17
10198956223479CARDINAL HEALTHCardinal Health 200, LLCOGS2025-10-23
10198956180819CARDINAL HEALTHCardinal Health 200, LLCOGS2025-08-27
50198956180817CARDINAL HEALTHCardinal Health 200, LLCOGS2025-08-27
10198956132733CARDINAL HEALTHCardinal Health 200, LLCOGS2025-07-31
50198956132731CARDINAL HEALTHCardinal Health 200, LLCOGS2025-07-31
10198956111936CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-30
50198956111934CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-30
10198956117242CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-16
50198956117240CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-16
10197106858844CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-29
50197106858842CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-29
10198956079984CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-21
50198956079982CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-21
10198956060364CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-29
50198956060362CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-29
10197106988398CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25
10198956060449CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25
50197106988396CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25