FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106862443
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
09-2214G
Catalog number
09-2214G
Device description
IMPLANT INSRTION TRY SCM309376
Published
2025-01-30
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
PVXVaginal Examination Tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106862443PackageGS140In Commercial Distribution
10197106862445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710686244350197106862443
1019710686244510197106862445

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
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

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
10197106819579CARDINAL HEALTHCardinal Health 200, LLCPVX2024-11-20
50197106819577CARDINAL 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