FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594456199
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA53LTECA
Catalog number
SMA53LTECA
Device description
LAP TUBAL PACK
Published
2021-12-22
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
FDElaparoscopy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDELaparoscopy KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594456199PackageGS12In Commercial Distribution
10195594456191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559445619950195594456199
1019559445619110195594456191

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, non-medicated, single-useA collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. 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
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
10198956428348CARDINAL HEALTHCardinal Health 200, LLCFDE2026-05-25
10198956438163CARDINAL HEALTHCardinal Health 200, LLCFDE2026-05-25
10198956442214CARDINAL HEALTHCardinal Health 200, LLCFDE2026-05-25
10198956455306CARDINAL HEALTHCardinal Health 200, LLCFDE2026-05-25
10198956466340CARDINAL HEALTHCardinal Health 200, LLCFDE2026-05-25
10198956470781CARDINAL HEALTHCardinal Health 200, LLCFDE2026-05-25
10198956477216CARDINAL HEALTHCardinal Health 200, LLCFDE2026-05-25
10198956484436CARDINAL HEALTHCardinal Health 200, LLCFDE2026-05-25
10198956485891CARDINAL HEALTHCardinal Health 200, LLCFDE2026-05-25
50198956285987CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-24
50198956316537CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956344547CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956370959CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956379013CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956397390CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956415902CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956422276CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956321920CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956325782CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956334043CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956340044CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956340051CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956343311CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956362756CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956365481CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956384475CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956256765CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956295610CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956346053CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956352917CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16