FDA.reportPublic FDA data

HALYARD

Primary DI
10809160527870
Brand
HALYARD
Company
AVID MEDICAL, INC.
Model
PVHM201-02
Catalog number
PVHM201-02
Published
2026-07-28
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
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160527877PackageGS14In Commercial Distribution
10809160527870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916052787720809160527877
1080916052787010809160527870

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
10809160528112HalyardSAMM041-08_0001SAMM041-082026-07-30
10809160528129HalyardNAMC434-09_0002NAMC434-092026-07-30
10809160528136HalyardNAFB062-09_0001NAFB062-092026-07-30
10809160528143HalyardGBEY17-02_0011GBEY17-022026-07-30
10809160528150HalyardPVHM222-02_0005PVHM222-022026-07-30
10809160528167HalyardSBHT00-06_0001SBHT00-062026-07-30
10809160528174HalyardDONS101-02_0001DONS101-022026-07-30
10809160528181HalyardQCEORSP123_0001QCEORSP1232026-07-30
10809160528198HalyardVMLR032-04_0005VMLR032-042026-07-30
10809160528051HalyardBPTJ33-01_0016BPTJ33-012026-07-29
10809160528075HalyardBMHT301-02_0007BMHT301-022026-07-29
10809160528082HalyardWINN121-11_0004WINN121-112026-07-29
10809160528099HalyardJCSP60F_0011JCSP60F2026-07-29
10809160528105HalyardESEY90-03_0016ESEY90-032026-07-29
10809160527856HalyardAVMD054_0004AVMD0542026-07-28
10809160527863HalyardAVMD052-02_0004AVMD052-022026-07-28
10809160527887HALYARDPVHM205-02PVHM205-022026-07-28
10809160527894HalyardOGDV68-02OGDV68-022026-07-28
10809160527900HalyardUPVD01-02UPVD01-022026-07-28
10809160527924HALYARDPVHM208-02PVHM208-022026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810135965088ToeJack Bunion Correction SystemNVision Biomedical Technologies, Inc.OJH2026-07-29
10809160527979HALYARDAVID MEDICAL, INC.OJH2026-07-28
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10198956361652CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956362857CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956364431CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956365308CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956369122CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956371910CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956372467CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956377585CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956389564CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956390263CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956391192CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956392182CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956397323CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956406087CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956439405CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956446687CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956449541CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956451261CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956452732CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956453999CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956458369CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956461673CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956461833CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956463172CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956467118CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27