FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439871850
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA14HYMF2
Catalog number
SMA14HYMF2
Device description
HYSTEROSCOPY PACK
Published
2020-07-27
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
50888439871850PackageGS12In Commercial Distribution
10888439871852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843987185050888439871850
1088843987185210888439871852

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
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
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