FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106101674
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
09-2214D
Catalog number
09-2214D
Device description
IMPLANT INSRTION TRY SCM309376
Published
2023-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50197106101672PackageGS140In Commercial Distribution
10197106101674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710610167250197106101672
1019710610167410197106101674

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

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004205Monoject1525SA1525SA2026-07-13
10192253004410Monoject8507MW8507MW2026-07-13
10192253004540Monoject8533SA8533SA2026-07-13
10192253004588Monoject8537MW8537MW2026-07-13
10192253004625SharpSafety8540SA8540SA2026-07-13
10192253004885Monoject8900MW8900MW2026-07-13
10192253005127Monoject8979MW8979MW2026-07-13
10192253005509Monoject8525Y8525Y2026-07-13
10192253071894Argyle47802478022026-07-13
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29

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
50197106819577CARDINAL HEALTHCardinal Health 200, LLCPVX2024-11-20
10197106325148CARDINAL HEALTHCardinal Health 200, LLCPVX2023-07-03
50197106325146CARDINAL HEALTHCardinal Health 200, LLCPVX2023-07-03
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