FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594781307
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA11GLSP6
Catalog number
SMA11GLSP6
Device description
GYN LAPAROSCOPY TRAY
Published
2022-08-17
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
50195594781307PackageGS13In Commercial Distribution
10195594781309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559478130750195594781307
1019559478130910195594781309

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 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
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
10198956359284CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956434547CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956436657CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956441958CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956445673CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956446649CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956457799CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956458000CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956465992CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956466036CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956467354CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956468092CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956473003CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956477155CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956477186CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956478466CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956480704CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956483156CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956484535CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956485327CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956486898CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956488625CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10198956489455CARDINAL HEALTHCardinal Health 200, LLCOHD2026-05-25
10809160521786HalyardAVID MEDICAL, INC.OHD2026-05-22
50198956314687CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956374148CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956382433CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956399301CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956418194CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956425581CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24