FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50887488928508
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
09-9247A
Catalog number
09-9247A
Device description
STANDARD PELVIC TRAY
Published
2018-03-26
Public version status
Update
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
MLTPelvic exam kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLTPelvic Exam KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50887488928508PackageGS120In Commercial Distribution
10887488928500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748892850850887488928508
1088748892850010887488928500

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

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
false
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
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956327320CARDINAL HEALTHCardinal Health 200, LLCMLT2026-03-09
10198956270275CARDINAL HEALTHCardinal Health 200, LLCMLT2025-12-11
10198956273535CARDINAL HEALTHCardinal Health 200, LLCMLT2025-12-11
10198956210851CARDINAL HEALTHCardinal Health 200, LLCMLT2025-11-21
10198459445217MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-28
10198459383748MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-02
10198459389207MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-02
10198459363726MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-06-09
10198459351747MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-06-02
10198956037649CARDINAL HEALTHCardinal Health 200, LLCMLT2025-05-21
10198459323713Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-18
10198459325137Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-18
10198459326226Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-18
10198459315817Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-07
10198956019089CARDINAL HEALTHCardinal Health 200, LLCMLT2025-04-03
10197106946367CARDINAL HEALTHCardinal Health 200, LLCMLT2025-03-17
10198459273551Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-03-02
10198459268724Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-02-23
10197106952085CARDINAL HEALTHCardinal Health 200, LLCMLT2025-02-17
10198459257025Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-02-09
10197106921029CARDINAL HEALTHCardinal Health 200, LLCMLT2025-01-28
10197106641224CARDINAL HEALTHCardinal Health 200, LLCMLT2025-01-09
10197106899830CARDINAL HEALTHCardinal Health 200, LLCMLT2025-01-09
10198459222047Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-29
10198459225567Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-29
10198459218002Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-22
10198459219467Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-22
10198459200762Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-01
10198459192463Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-11-24
10198459173226Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-11-17