FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885425616022
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA48HYWLE
Catalog number
SMA48HYWLE
Device description
STERILE HYSTEROSCOPY PACK
Published
2016-06-27
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
50885425616020PackageGS14In Commercial Distribution
10885425616022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088542561602050885425616020
1088542561602210885425616022

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.

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
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956477001CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956505612CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956509344CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956525184CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956526747CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
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