FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956486140
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PB11FSC16
Catalog number
PB11FSC16
Device description
KIT, FETAL SURGERY
Published
2026-06-01
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
OHDGynecological laparoscopic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956486148PackageGS11In Commercial Distribution
10198956486140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895648614850198956486148
1019895648614010198956486140

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 Temperature00

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
50192253071595CONVERTORS8184NA8184NA2026-06-02
50192253071601CONVERTORS8187N8187N2026-06-02
50192253071618CONVERTORS8188NC8188NC2026-06-02
50192253071625CONVERTORS8189N8189N2026-06-02
20192253005971CONVERTORSAT7004AT70042019-04-16
20192253017080Kendall31.3876.0431.3876.042023-03-16
50885380183001CARDINAL HEALTH50001218500012182023-08-11
50885380182998CARDINAL HEALTH50001217500012172023-08-11
10197106817643CARDINAL HEALTHSEYHBDPANBSEYHBDPANB2026-06-01
10198956004887CARDINAL HEALTHSBAHFRPASCSBAHFRPASC2026-06-01
10198956201804CARDINAL HEALTH32-0828C32-0828C2026-06-01
10198956209220CARDINAL HEALTHPG33GLVWBPG33GLVWB2026-06-01
10198956225992CARDINAL HEALTHSOP54PPUOBSOP54PPUOB2026-06-01
10198956245754CARDINAL HEALTHSBACGKTACFSBACGKTACF2026-06-01
10198956248908CARDINAL HEALTHSAN43CATOBSAN43CATOB2026-06-01
10198956269323CARDINAL HEALTHSOP4QSHCLBSOP4QSHCLB2026-06-01
10198956311282CARDINAL HEALTHSCV11VSJKJSCV11VSJKJ2026-06-01
10198956312043CARDINAL HEALTHPW30PSPRHPW30PSPRH2026-06-01
10198956314634CARDINAL HEALTHSBAMIFPACBSBAMIFPACB2026-06-01
10198956314894CARDINAL HEALTHSEN42HNAMDSEN42HNAMD2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956209220CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-01
10198956452602CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-01
10198956464568CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-01
10198956466197CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-01
10198956489059CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-01
10198956489158CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-01
10198956489547CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-01
10198956491281CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-01
10198956492288CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-01
10198956494220CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-01
10193489212686Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489212914Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489216318Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489217025Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489413335Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489413854Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489413960Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489419078Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489424027Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489424348Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489425017Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489425536Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489425611Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489428353Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489429619Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489430608Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489438529Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489441369Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489443080Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489443868Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08