FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106819577
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
09-2214F
Catalog number
09-2214F
Device description
IMPLANT INSRTION TRY SCM309376
Published
2024-11-20
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
PVXVaginal Examination Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PVXVaginal Examination TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106819577PackageGS140In Commercial Distribution
10197106819579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710681957750197106819577
1019710681957910197106819579

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, medicatedA collection of various sterile surgical instruments, dressings, pharmaceuticals, and materials intended to be used during obstetrical/gynaecological surgery; it is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05010058074026InstrapacROBINSON HEALTHCARE LIMITEDPVX2025-06-23
05010058074040InstrapacROBINSON HEALTHCARE LIMITEDPVX2025-06-23
05010058174023InstrapacROBINSON HEALTHCARE LIMITEDPVX2025-06-23
05010058174047InstrapacROBINSON HEALTHCARE LIMITEDPVX2025-06-23
10197106862445CARDINAL HEALTHCardinal Health 200, LLCPVX2025-01-30
50197106862443CARDINAL HEALTHCardinal Health 200, LLCPVX2025-01-30
10197106819579CARDINAL HEALTHCardinal Health 200, LLCPVX2024-11-20
10197106325148CARDINAL HEALTHCardinal Health 200, LLCPVX2023-07-03
50197106325146CARDINAL HEALTHCardinal Health 200, LLCPVX2023-07-03
10197106101674CARDINAL HEALTHCardinal Health 200, LLCPVX2023-03-20
50197106101672CARDINAL HEALTHCardinal Health 200, LLCPVX2023-03-20
H65857032395Henry ScheinHENRY SCHEIN, INC.PVX2022-12-13
H65857032305Henry ScheinHENRY SCHEIN, INC.PVX2022-11-22
H65857032301Henry ScheinHENRY SCHEIN, INC.PVX2022-11-22
10195594890438CARDINAL HEALTHCardinal Health 200, LLCPVX2022-10-21
50195594890436CARDINAL HEALTHCardinal Health 200, LLCPVX2022-10-21
M75257031520Stradis STRADIS MEDICAL, LLCPVX2022-09-01
M75257026250STRADIS HEALTHCARESTRADIS MEDICAL, LLCPVX2022-04-28
H65857029645Henry ScheinHENRY SCHEIN, INC.PVX2022-04-07
H65857029641Henry ScheinHENRY SCHEIN, INC.PVX2022-04-07
H65857029555Henry ScheinHENRY SCHEIN, INC.PVX2022-03-31
H65857029551Henry ScheinHENRY SCHEIN, INC.PVX2022-03-31
M7526180360STRADIS HEALTHCARESTRADIS MEDICAL, LLCPVX2022-03-21
M7526180310STRADIS HEALTHCARESTRADIS MEDICAL, LLCPVX2022-03-10
M75257015130STRADIS HEALTHCARESTRADIS MEDICAL, LLCPVX2022-03-09
M7526180350STRADIS HEALTHCARESTRADIS MEDICAL, LLCPVX2022-03-09
10195594960384CARDINAL HEALTHCardinal Health 200, LLCPVX2021-04-06
50195594960382CARDINAL HEALTHCardinal Health 200, LLCPVX2021-04-06
10888439843606CARDINAL HEALTHCardinal Health 200, LLCPVX2020-11-09
10888439589399CARDINAL HEALTHCardinal Health 200, LLCPVX2019-10-17