FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106061396
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBADHGLFAA
Catalog number
SBADHGLFAA
Device description
GYN LAPAROSCOPY PACK
Published
2023-08-18
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
OHAHeart valve, more than minimally manipulated allograft

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHAHeart Valve, More Than Minimally Manipulated AllograftUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106061396PackageGS13In Commercial Distribution
10197106061398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710606139650197106061396
1019710606139810197106061398

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 Temperature15 Degrees Celsius30 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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956105797CARDINAL HEALTHCardinal Health 200, LLCOHA2025-06-10
50198956108750CARDINAL HEALTHCardinal Health 200, LLCOHA2025-06-10
50197106815739CARDINAL HEALTHCardinal Health 200, LLCOHA2024-11-01
50197106751693CARDINAL HEALTHCardinal Health 200, LLCOHA2024-10-25
50197106769834CARDINAL HEALTHCardinal Health 200, LLCOHA2024-10-08
50197106748785CARDINAL HEALTHCardinal Health 200, LLCOHA2024-09-19
50197106748792CARDINAL HEALTHCardinal Health 200, LLCOHA2024-09-11
50197106687886CARDINAL HEALTHCardinal Health 200, LLCOHA2024-07-03
50197106652549CARDINAL HEALTHCardinal Health 200, LLCOHA2024-06-15
50197106627868CARDINAL HEALTHCardinal Health 200, LLCOHA2024-05-16
50197106638628CARDINAL HEALTHCardinal Health 200, LLCOHA2024-04-17
50197106621040CARDINAL HEALTHCardinal Health 200, LLCOHA2024-04-10
50197106589456CARDINAL HEALTHCardinal Health 200, LLCOHA2024-03-28
50197106571833CARDINAL HEALTHCardinal Health 200, LLCOHA2024-02-14
50197106428809CARDINAL HEALTHCardinal Health 200, LLCOHA2023-12-05
50197106294046CARDINAL HEALTHCardinal Health 200, LLCOHA2023-11-28
50197106431960CARDINAL HEALTHCardinal Health 200, LLCOHA2023-10-12
50197106432035CARDINAL HEALTHCardinal Health 200, LLCOHA2023-10-04
50197106443475CARDINAL HEALTHCardinal Health 200, LLCOHA2023-10-03
50197106444816CARDINAL HEALTHCardinal Health 200, LLCOHA2023-09-29
50197106277643CARDINAL HEALTHCardinal Health 200, LLCOHA2023-06-29
50197106271139CARDINAL HEALTHCardinal Health 200, LLCOHA2023-05-04
50197106175994CARDINAL HEALTHCardinal Health 200, LLCOHA2023-04-17
50197106139026CARDINAL HEALTHCardinal Health 200, LLCOHA2023-04-04
50197106192632CARDINAL HEALTHCardinal Health 200, LLCOHA2023-03-21
50197106139545CARDINAL HEALTHCardinal Health 200, LLCOHA2023-02-16
50197106125319CARDINAL HEALTHCardinal Health 200, LLCOHA2023-02-08
50197106121762CARDINAL HEALTHCardinal Health 200, LLCOHA2023-02-07
50197106050765CARDINAL HEALTHCardinal Health 200, LLCOHA2022-12-05
50197106044450CARDINAL HEALTHCardinal Health 200, LLCOHA2022-12-02