FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106641224
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMAHFAPNUC
Catalog number
SMAHFAPNUC
Device description
ANTERIOR PELVIC REPAIR PACK
Published
2025-01-09
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
MLTPelvic exam kit

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106641222PackageGS13In Commercial Distribution
10197106641224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710664122250197106641222
1019710664122410197106641224

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic examination kitA collection of sterile devices designed to perform a pelvic examination. It contains all of the various instruments, specimen collection materials, and pharmaceuticals necessary for this procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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
10653160388982MEDLINEMEDLINE INDUSTRIES, INC.MLT2025-08-02
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
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