FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10887488035802
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA57MVOHK
Catalog number
SMA57MVOHK
Device description
STR AMB MINOR VAG PROCEDURE PK
Published
2016-07-28
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
OHDGynecological laparoscopic kit

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50887488035800PackageGS14In Commercial Distribution
10887488035802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748803580050887488035800
1088748803580210887488035802

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
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
10198956436626CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956465176CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956467651CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956488922CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956489691CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956493919CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956495135CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956495982CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956496125CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956496132CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956496576CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956497825CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956500167CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956344471CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-05
10198956404670CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-05
10198956430204CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-05
10198956492240CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-05
10198956493155CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-05
10198956494893CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-05
10198956177055CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-03
10198956198456CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-03
10198956461314CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-03
10198956463745CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-03
10198956479623CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-03
10198956485280CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-03
10198956489677CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-03
10198956491465CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-03
10198956209220CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-01
10198956452602CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-01
10198956464568CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-01