FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885425496341
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
09-9000
Catalog number
09-9000
Device description
PELVIC EXAM TRAY
Published
2016-06-30
Public version status
Update
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
MLTKit, pelvic exam

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885425496349PackageGS120In Commercial Distribution
10885425496341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088542549634950885425496349
1088542549634110885425496341

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.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956490789CARDINAL HEALTHCardinal Health 200, LLCMLT2026-07-06
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