FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439515374
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
09-2214A
Catalog number
09-2214A
Device description
IMPLANT INSRTION TRY SCM309376
Published
2019-06-21
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
50888439515372PackageGS140In Commercial Distribution
10888439515374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843951537250888439515372
1088843951537410888439515374

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
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

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
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