FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106802876
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA40HSJU2
Catalog number
SMA40HSJU2
Device description
HYSTEROSCOPY SURGERY CTR PACK
Published
2024-10-22
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
50197106802876PackageGS12In Commercial Distribution
10197106802878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710680287650197106802876
1019710680287810197106802878

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, medicatedA collection of various sterile surgical and endoscopic instruments (e.g., trocars, sleeves, cannulae), dressings, pharmaceuticals, and the necessary materials used to perform a laparoscopic surgical procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

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
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956359291CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956464520CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956468481CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956497757CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956524378CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956558182CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956561441CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956570641CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956570658CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956571693CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-04
10198956494053CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956546554CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956547599CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956550315CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956552579CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956561410CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956563551CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956565289CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956520851CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-18
10198956406964CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956427020CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956498419CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956505780CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956508828CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956520493CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956547841CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10809160528334HALYARDAVID MEDICAL, INC.OHD2026-08-01
10198956368125CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956393295CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956460669CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31